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    Celltrion USA announces distribution and incorpora..
    Celltrion USA announces distribution and incorporation of YUFLYMA® (adalimumab-aaty), a Humira® biosimilar, to CarePartners Specialty Pharmacy Cost Savings ProgramsYUFLYMA® (adalimumab-aaty) was first approved by the Food and Drug Administration on May 23, 2023 and became commercially available in the U.S. on July 2, 2023The treatment will be available on CarePartners Specialty Pharmacy Program in late October and will make YUFLYMA accessible to over 10 million livesThe inclusion of YUFLYMA creates greater accessibility to treatments for AmericansOctober 26, 2023 11:59 AM Eastern Daylight TimeJERSEY CITY, N.J.--(BUSINESS WIRE)--Celltrion USA, Inc. (Celltrion USA) today announced its FDA-approved biosimilar, YUFLYMA® (adalimumab-aaty), has been added to CarePartners Specialty Pharmacy Cost Savings Programs. YUFLYMA is a high-concentration (100mg/mL) and citrate-free formulation of the Humira® (adalimumab) biosimilar. CarePartners and its strategic partners will offer and distribute YUFLYMA as the lowest net cost high-concentration Humira (adalimumab) biosimilar to over 10 million plan members.“Care Partners’ decision to add YUFLYMA to its formulary could benefit millions of Americans, bringing value to the healthcare system and patient communities,” said Thomas Nusbickel, Chief Commercial Offer at Celltrion USA. “We are dedicated to improving the lives of patients by expanding biosimilar access and affordability with treatment options backed by a strong, evidence-based efficacy-safety profile.”More than 80% of patients treated with Humira in the U.S. rely on a high-concentration and citrate-free formulation.1 YUFLYMA provides additional benefits of administration via a latex-free device and a longer shelf life due to its ability to maintain a stability at 77°F for a period up to 30 days, with protection from light.“We are excited to partner with Celltrion to offer a quality, high-concentration alternative to Humira at the lowest net-cost,” said Kam Ghazvini, RPh, Founder and CEO of CarePartners. “Partnering with Celltrion to offer YUFLYMA solidifies our cost saving initiatives for plan sponsors, employers, health plans, and other payers. We are excited to support Celltrion, a leading biotech company poised to be one of the leaders in the biosimilar landscape with a rich pipeline of blockbuster biosimilars in the years to come.”On September 29, the U.S. Food and Drug Administration (FDA) has approved additional strengths for YUFLYMA, a high-concentration (100mg/mL) and citrate-free formulation of Humira(adalimumab) biosimilar, in 20mg and 80mg strengths in the United States.<End>About YUFLYMA® (CT-P17, biosimilar adalimumab-aaty)2YUFLYMA was the first high-concentration, low-volume, and citrate-free adalimumab biosimilar to receive European Commission approval in the European Union. YUFLYMA is FDA approved for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and Hidradenitis Suppurativa. YUFLYMA is a recombinant fully human anti–tumor necrosis factor α (anti-TNFα) monoclonal antibody. Following the launch of 40mg/0.4mL in the U.S. in July 2023, two different types of dosage forms, 80mg/0.8mL, 20mg/0.2mL, were approved by the FDA on September 29, 2023. The full prescribing information can be found at: https://www.celltrionusa.com/data/file/product/Yuflyma%20USPI.pdfINDICATIONSYUFLYMA is a tumor necrosis factor (TNF) blocker indicated for:Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RAJuvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and olderPsoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsAAnkylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active ASCrohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and olderUlcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adultsLimitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockersPlaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriateHidradenitis Suppurativa (HS): treatment of adult patients with moderate to severe hidradenitis suppurativaYUFLYMA® IMPORTANT SAFETY INFORMATIONSERIOUS INFECTIONSPatients treated with YUFLYMA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.Discontinue YUFLYMA if a patient develops a serious infection or sepsis.Reported infections include:Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before YUFLYMA use and during therapy. Initiate treatment for latent TB prior to YUFLYMA use.Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric antifungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.Carefully consider the risks and benefits of treatment with YUFLYMA prior to initiating therapy in patients with chronic or recurrent infection.Monitor patients closely for the development of signs and symptoms of infection during and after treatment with YUFLYMA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.Treatment with YUFLYMA should not be initiated in patients with an active infection, including localized infections.Patients over 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants (such as corticosteroids or methotrexate), may be at greater risk of infection. Discontinue YUFLYMA if a patient develops a serious infection or sepsis. For a patient who develops a new infection during treatment with YUFLYMA, closely monitor them, perform a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and initiate appropriate antimicrobial therapy.Drug interactions with biologic products: In clinical studies in patients with RA, an increased risk of serious infections has been observed with the combination of TNF blockers with anakinra or abatacept, with no added benefit; therefore, use of YUFLYMA with abatacept or anakinra is not recommended in patients with RA. A higher rate of serious infections has also been observed in patients with RA treated with rituximab who received subsequent treatment with a TNF blocker. There is insufficient information regarding the concomitant use of YUFLYMA and other biologic products for the treatment of RA, PsA, AS, CD, UC, PS, and HS. Concomitant administration of YUFLYMA with other biologic DMARDS (e.g., anakinra and abatacept) or other TNF blockers is not recommended based upon the possible increased risk for infections and other potential pharmacological interactions. A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker.MALIGNANCYLymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab products.Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.Consider the risks and benefits of TNF blocker treatment including YUFLYMA prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC), or when considering continuing a TNF blocker in patients who develop a malignancy.In controlled portions of clinical trials of some adalimumab products, more cases of malignancies have been observed compared to control-treated adult patients.Non-melanoma skin cancer (NMSC) was reported during clinical trials for patients treated with adalimumab products. During the controlled portions of 39 global adalimumab clinical trials in adult patients with RA, PsA, AS, CD, UC, PS and HS, the rate (95% confidence interval) of NMSC was 0.8 (0.52, 1.09) per 100 patient-years among adalimumab-treated patients and 0.2 (0.10, 0.59) per 100 patient-years among control-treated patients. Examine all patients, particularly those with a medical history of prior prolonged immunosuppressant therapy or psoriasis patients with a history of PUVA treatment, for the presence of NMSC prior to and during treatment with YUFLYMA.In clinical trials of some adalimumab products, there was an approximate threefold higher rate of lymphoma than expected in the general U.S. population. Patients with RA and other chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at a higher risk (up to several fold) than the general population for the development of lymphoma, even in the absence of TNF blockers.Postmarketing cases of acute and chronic leukemia were reported with use of a TNF blocker in RA and other indications. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving adalimumab were lymphomas; other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents.HYPERSENSITIVITYAnaphylaxis and angioneurotic edema have been reported following administration of adalimumab products. If an anaphylactic or other serious allergic reaction occurs, immediately discontinue administration of YUFLYMA and institute appropriate therapy.HEPATITIS B VIRUS REACTIVATIONUse of TNF blockers, including YUFLYMA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. In some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal.Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy.Exercise caution in prescribing TNF blockers for patients identified as carriers of HBV and closely monitor such patients for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy.In patients who develop HBV reactivation, stop YUFLYMA and initiate effective antiviral therapy with appropriate supportive treatment. The safety of resuming TNF blocker therapy after HBV reactivation is controlled is not known. Therefore, exercise caution when considering resumption of YUFLYMA therapy in this situation and monitor patients closely.NEUROLOGIC REACTIONSUse of TNF blocking agents, including adalimumab products, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis (MS) and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome.Exercise caution in considering the use of YUFLYMA in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of YUFLYMA should be considered if any of these disorders develop.There is a known association between intermediate uveitis and central demyelinating disorders.HEMATOLOGIC REACTIONSRare reports of pancytopenia including aplastic anemia have been reported with TNF blocking agents.Adverse reactions of the hematologic system, including medically significant cytopenia, have been infrequently reported with adalimumab products.Consider discontinuation of YUFLYMA therapy in patients with confirmed significant hematologic abnormalities.HEART FAILURECases of worsening congestive heart failure (CHF) and new-onset CHF have been reported with TNF blockers. Cases of worsening CHF have also been observed with adalimumab products.Exercise caution when using YUFLYMA in patients who have heart failure and monitor them carefully.AUTOIMMUNITYTreatment with adalimumab products may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with YUFLYMA, discontinue treatment.IMMUNIZATIONSPatients on YUFLYMA may receive concurrent vaccinations, except for live vaccines.It is recommended that pediatric patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating YUFLYMA therapy.No data are available on the secondary transmission of infection by live vaccines in patients receiving adalimumab products.The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants.ADVERSE REACTIONSThe most common adverse reactions in adalimumab clinical trials (>10%) were infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.Please see full Prescribing Information for YUFLYMA® (adalimumab-aaty)About Celltrion USACelltrion USA is Celltrion Healthcare’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion USA will continue to leverage Celltrion Healthcare’s unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. Celltrion Healthcare endeavors to offer high-quality, cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information, please visit: www.celltrionusa.com/About CarePartnersCarePartners is a specialty pharmacy business focused on providing chronic and complex therapies including specialty infusion, specialty pharmacy, and ambulatory infusion services. The CarePartners team is made up of experienced clinicians and experienced support staff dedicated to providing patients with the highest quality service, leveraging a high-touch patient centric model. CarePartners offers innovative cost saving programs with positive clinical outcomes to plan sponsors, employers, unions, PBMs, and health plans. www.CarePartnersRx.comCarePartners is fully accredited and is licensed to service patients in all 50 states and DC.References1. Symphony Health, IQVIA2. YUFLYMA US prescribing information (2023)
    2023-10-27
  • 7
    Celltrion USA Announces U.S. FDA Approval of ZYMFE..
    Celltrion USA Announces U.S. FDA Approval of ZYMFENTRA™ (infliximab-dyyb), the First and Only Subcutaneous infliximab, for the Treatment of People With Inflammatory Bowel DiseaseZYMFENTRA™ is the first and only FDA-approved subcutaneous (SC) formulation of infliximab approved for the maintenance treatment of adult patients with moderately to severely active ulcerative colitis and Crohn’s diseaseNovel subcutaneous administration of ZYMFENTRA delivers stable elevated serum infliximab levelsApproval of ZYMFENTRA provides an alternative administration option for physicians and patientsOctober 22, 2023 07:12 PM Eastern Daylight TimeJERSEY CITY, N.J.--(BUSINESS WIRE)--Today, Celltrion USA announced that the U.S. Food and Drug Administration (FDA) has approved ZYMFENTRA™ (infliximab-dyyb) for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD) following treatment with an infliximab product administered intravenously.1Following the submission of a Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act (a “stand-alone” BLA) in December 2022, the FDA approved ZYMFENTRA based on phase III pivotal data that evaluated the efficacy and safety of ZYMFENTRA as maintenance therapy in patients with moderately to severely active UC (LIBERTY-UC) and CD (LIBERTY-CD). Based on the results of the LIBERTY UC and LIBERTY CD studies, ZYMFENTRA demonstrated superiority in the primary endpoints of clinical remission (UC and CD) and endoscopic response (CD) compared to placebo as maintenance therapy after induction therapy of intravenous formulation of infliximab in patients with UC and CD, over a 54-week study period. The overall safety profile of ZYMFENTRA was similar to that of placebo during maintenance period in both studies with no new safety signals seen.2,3“There remains an unmet need for patients who suffer from the day-to-day burden of living with moderately to severely active Crohn’s disease and ulcerative colitis,” said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. “The approval of ZYMFENTRA provides an innovative and effective treatment option that offers patients with IBD an alternative administration option providing control of how and where they receive their treatment, reinforcing our commitment to providing high-quality and affordable treatment options that deliver substantial value to patients and our healthcare system.”“As a healthcare professional dedicated to improving the lives of patients with IBD, I am excited to see further data that validate a convenient treatment option that could allow more patients in the U.S. to have greater control of their disease management,” said Dr. Jean-Frederic Colombel of Icahn School of Medicine at Mount Sinai.“As someone dedicated to improving the lives of patients with IBD, I am excited to see data supporting the efficacy and safety of a new formulation offering convenience and improved access to a well-known and proven drug,” said Dr. Andres Yarur of Cedars-Sinai Medical Center.ZYMFENTRA will be under patent protection by 2037 for its dosage form and route of administration by 2040.About the pivotal LIBERTY-UC studyThe LIBERTY-UC is a randomized, placebo-controlled, double-blind, phase III study designed to evaluate the superiority of subcutaneous ZYMFENTRA relative to placebo treatment in efficacy and safety during maintenance therapy in patients with moderate to severe active UC after induction therapy of intravenous formulation of infliximab. A total of 438 patients with response after induction were randomized at Week 10. The rate of clinical remission at Week 54 was significantly greater in ZYMFENTRA (43.2%) compared to placebo (20.8%) (P<0.0001). The safety profile during maintenance phase was generally comparable between ZYMFENTRA and placebo arms. Most common adverse events are COVID-19, anemia, arthralgia, injection site reaction, increased alanine aminotransferase, and abdominal pain.About the pivotal LIBERTY-CD studyThe LIBERTY-CD is a randomized, placebo-controlled, double-blind, phase III study designed to evaluate the superiority of the subcutaneous ZYMFENTRA relative to placebo treatment in efficacy and safety during maintenance therapy in patients with moderate to severe active CD after induction therapy of intravenous formulation of infliximab. A total of 343 patients with response after induction were randomized at Week 10. At Week 54, the clinical remission rate was greater in ZYMFENTRA than placebo arm (62.3% and 32.1% respectively, with P <0.0001). In parallel, the endoscopic response rate at week 54 was also greater in ZYMFENTRA arm than placebo arm (51.1% and 17.9% respectively, with P <0.0001). The safety profile during maintenance phase was generally comparable between ZYMFENTRA and placebo arms. Most common adverse events are COVID-19, upper respiratory tract infection, headache, injection site reaction, diarrhea, increased alanine aminotransferase, and increased blood creatine phosphokinase, neutropenia, hypertension, urinary tract infection, dizziness, and leukopenia.About ZYMFENTRA™ (infliximab-dyyb)ZYMFENTRA is a subcutaneous version of Celltrion’s infliximab biosimilar. ZYMFENTRA blocks the action of tumor necrosis factor-alpha (TNF-alpha), a protein that can be overproduced in response to certain diseases and cause the immune system to attack normal, healthy parts of the body.The infliximab biosimilar developed and manufactured by Celltrion was the world's first monoclonal antibody biosimilar. It is indicated for the treatment of eight autoimmune diseases including Crohn’s disease (CD) and ulcerative colitis (UC). It was approved by the European Commission under the trade name REMSIMA® in September 2013 and launched in major EU countries in early 2015. The U.S. Food and Drug Administration approved the biosimilar in April 2016 under the trade name INFLECTRA®.Subcutaneous infliximab (trademarked as REMSIMA® SC in the EU) has received EU marketing authorization for the treatment of people with CD, UC, rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), and psoriasis in adult patients. In the U.S., ZYMFENTRA has received FDA approval for the maintenance treatment of adult patients with moderately to severely active UC and CD.About Celltrion USACelltrion USA is Celltrion Healthcare’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion currently has five biosimilars approved by the U.S. FDA: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), and YUFLYMA®(adalimumab-aaty). Celltrion USA will continue to leverage Celltrion Healthcare’s unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients.ZYMFENTRA (infliximab-dyyb) U.S. Use and Important Safety InformationZYMFENTRA is a prescription medicine indicated in adults for maintenance treatment of:moderately to severely active Crohn’s disease following treatment with an infliximab product administered intravenously.moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously.It is not known if ZYMFENTRA is safe and effective in children under 18 years of age.What is the most important information I should know about ZYMFENTRA?SERIOUS INFECTIONSPatients treated with ZYMFENTRA are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Discontinue ZYMFENTRA if a patient develops a serious infection or sepsis.Reported infections include:• Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before and during treatment with ZYMFENTRA. Treatment for latent infection should be initiated prior to treatment with ZYMFENTRA.• Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients may present with disseminated, rather than localized, disease. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.• Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.The risks and benefits of treatment with ZYMFENTRA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with ZYMFENTRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.Risk of infection may be higher in patients greater than 65 years of age, patients with comorbid conditions and/or patients taking concomitant immunosuppressant therapy. In clinical trials, other serious infections observed in patients treated with infliximab included arthritis bacterial, pneumonia, and urinary tract infection.MALIGNANCIESMalignancies, some fatal, have been reported in children, adolescents, and young adults treated with TNF blockers, including infliximab products.Approximately half of these cases were lymphomas, including Hodgkin’s and non-Hodgkin’s lymphoma. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants.Postmarketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including infliximab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported cases have occurred in patients with Crohn’s disease or ulcerative colitis and most were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. Carefully assess the risks and benefits of treatment with ZYMFENTRA, especially in these patient types.In clinical trials of all TNF blockers, more cases of malignancies were observed compared with controls and the expected rate in the general population. In clinical trials of some TNF blockers, including infliximab products, more cases of other malignancies were observed compared with controls. As the potential role of TNF blocker therapy in the development of malignancies is not known, caution should be exercised when considering treatment of patients with a current or a past history of malignancy.Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocker therapy, including infliximab products. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.CONTRAINDICATIONSZYMFENTRA is contraindicated in patients with a previous severe hypersensitivity reaction to infliximab-dyyb, other infliximab products, any of the inactive ingredients of ZYMFENTRA or any murine proteins (severe hypersensitivity reactions have included anaphylaxis, hypotension, and serum sickness).HEPATITIS B VIRUS REACTIVATIONTNF blockers, including infliximab products, have been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases were fatal. Patients should be tested for HBV infection before initiating ZYMFENTRA. For patients who test positive, consult a physician with expertise in the treatment of hepatitis B. Exercise caution when prescribing ZYMFENTRA for patients identified as carriers of HBV, and monitor closely for active HBV infection during and following termination of therapy with ZYMFENTRA. Discontinue ZYMFENTRA in patients who develop HBV reactivation, and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of ZYMFENTRA, and monitor patients closely.HEPATOTOXICITYHepatobiliary disorders, including acute liver failure, jaundice abnormal hepatic function, hepatic steatosis, hepatitis, hepatotoxicity, hyperbilirubinemia, and non-alcoholic fatty liver, have been reported in patients receiving infliximab products postmarketing. Some cases were fatal or required liver transplant. Aminotransferase elevations were not noted prior to discovery of liver injury in many cases. Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. If jaundice and/or marked liver enzyme elevations (eg, ≥5 times the upper limit of normal) develop, ZYMFENTRA should be discontinued, and a thorough investigation of the abnormality should be undertaken.CONGESTIVE HEART FAILURECases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers. Some cases had a fatal outcome. In several exploratory trials of other TNF blockers in the treatment of CHF, there were greater proportions of TNF-blocker-treated patients who had CHF exacerbations requiring hospitalization or increased mortality. ZYMFENTRA has not been studied in patients with a history of CHF and ZYMFENTRA should be used with caution in patients with CHF.HEMATOLOGIC REACTIONCases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia (some fatal) have been reported. The causal relationship to infliximab-product therapy remains unclear. Exercise caution in patients who have ongoing or a history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs and symptoms of blood dyscrasias or infection. Consider discontinuation of ZYMFENTRA in patients who develop significant hematologic abnormalities.HYPERSENSITIVITY AND OTHER ADMINISTRATION REACTIONSIn post-marketing experience, serious systemic hypersensitivity reactions (including anaphylaxis, hypotension, and serum sickness) have been reported following administration of infliximab products. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue ZYMFENTRA.INJECTION SITE REACTIONSIn clinical studies, localized injection-site reactions were reported following administration of ZYMFENTRA. If a clinically significant injection-site reaction occurs, institute appropriate therapy and discontinue ZYMFENTRA.NEUROLOGIC REACTIONSAgents that inhibit TNF have been associated with central nervous system (CNS) manifestation of systemic vasculitis, seizure, and new onset or exacerbation of CNS demyelinating disorders, including multiple sclerosis and optic neuritis, and peripheral demyelinating disorders, including Guillain-Barré syndrome. Exercise caution when considering ZYMFENTRA in patients with these disorders and consider discontinuation if these disorders develop.RISK OF INFECTION WITH CONCURRENT ADMINISTRATION OF OTHER BIOLOGICS PRODUCTSSerious infections and neutropenia have been reported with concurrent use of ZYMFENTRA with other immunosuppressive biological products. The concurrent use of ZYMFENTRA with other immunosuppressive biological products used to treat UC and CD may increase the risk of infection and is not recommended.RISK OF ADDITIVE IMMUNOSUPPRESSIVE EFFECTS FROM PRIOR BIOLOGICAL PRODUCTSConsider the half-life and mode of action of prior biological products to avoid unintended additive immunosuppressive effects when initiating ZYMFENTRA.AUTOIMMUNITYTreatment with TNF blockers may result in the formation of autoantibodies and in the development of a lupus-like syndrome. Discontinue ZYMFENTRA treatment if symptoms of a lupus-like syndrome develop.VACCINATIONS AND USE OF LIVE VACCINES/THERAPEUTIC INFECTIOUS AGENTSPrior to initiating ZYMFENTRA, update vaccinations in accordance with current vaccination guidelines. Live vaccines or therapeutic infectious agents should not be given with ZYMFENTRA due to the possibility of clinical infections, including disseminated infections. At least a 6-month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to ZYMFENTRA.ADVERSE REACTIONSIn clinical trials with ZYMFENTRA, the most common adverse reactions occurring in ≥3% of ZYMFENTRA-treated patients included site reactions, COVID-19, anemia, arthralgia, infection site reaction, increased alanine aminotransferase and abdominal pain for UC, and COVID-19, headache, upper respiratory tract infection, injection site reaction, diarrhea, increased blood creatine phosphokinase, arthralgia, increased alanine aminotransferase, hypertension, urinary tract infection, neutropenia, dizziness and leukopenia for CD.This is the most important information to know about ZYMFENTRA. For more information, talk to your HCP.Please click for Full U.S. Prescribing Information.Globally, prescribing information varies; refer to the individual country product label for complete information.References____________________________1 Zymfentra Prescribing Information2 Hanauer SB et al., Subcutaneous infliximab (CT-P13) as maintenance therapy for Crohn’s disease: A phase 3, randomized, placebo-controlled study (LIBERTY-CD). Gastroenterology. 2023;164(Supplement_6):S220-S221; [Digestive Disease Week 2023, Presentation number 1028].3 Sands BE et al., Subcutaneous infliximab (CT-P13 SC) as maintenance therapy for ulcerative colitis: A phase 3, randomized, placebo-controlled study: Results of the LIBERTY-UC study. Gastroenterology. 2023;164(Supplement_6):S1083-S1084; [Digestive Disease Week 2023, Presentation number Tu1701].
    2023-10-23
  • 6
    Celltrion USA has signed a contract with Ventegra®..
    Celltrion USA has signed a contract with Ventegra® to add Yuflyma® (adalimumab-aaty) as a preferred formulary product in both public and private insurance markets- By inclusion in Ventegra’s formularies, Yuflyma® has secured access through the appropriate channel for about 3.6% of the U.S. populationOctober 05, 2023 04:52 PM Eastern Daylight TimeJERSEY CITY, N.J.--(BUSINESS WIRE)--Celltrion USA has signed a contract with Ventegra ®, a major U.S. Medical Benefits Manager (MBM) who administers pharmacy benefits through its Pharmacy Services Administration (PSA) model that has been effectively displacing traditional PBM’s. Ventegra will incorporate Yuflyma® (adalimumab-aaty) as a preferred drug in its formulary. As a result, Celltrion expands its performance in the U.S., the world's largest adalimumab market.Celltrion USA had completed a contract with Ventegra to include Yuflyma® as a preferred drug in its formulary starting from the middle of September. Some administrative procedures such as uploading the updated formulary into its systems, should be completed by the first part of October 2023. By inclusion onto Ventegra’s formulary in both public and private insurance markets, Celltrion USA has secured access in the appropriate channel for approximately 3.6% of the entire U.S.“After an exhaustive evaluation process, we are pleased to be working with Celltrion on launching Yuflyma as a formulary option and look forward to their extensive pipeline of biosimilar products,” said Robert T. Taketomo, Pharm.D., MBA, President/CEO of Ventegra.Celltrion USA emphasized that it has concluded a deal with Ventegra based on Yuflyma’s product competitiveness, technology, commercial capabilities, supply stability, patient support programs, and clinical credibility. In total, Celltrion has secured about 20% of the U.S. population so far by adding meaningful achievements with PBMs and MBM’s such as Ventegra.Celltrion USA is confident that Yuflyma® will be added to more PBM and MBM formularies over time. It has expanded discussions with stakeholders, including PBMs and other healthcare entities, in accordance with the company’s sales strategies. As marketing activities such as ‘Celltrion CONNECT® Patient Support Program’ are implemented, interest in Yuflyma® is expected to escalate. Celltrion USA expects that it will be able to provide interested parties with more favorable terms and conditions because Yuflyma® will have further strengthened its competitiveness through the expected approval of 80mg and 20mg dosage forms by the end of this year. Celltrion USA plans to expand its marketing activities so that Yuflyma® has coverage and/or access for 40% of the U.S. population by the end of the year.“In the United States, we are committed to increasing patient choice through access to biosimilars,” said Francine Galante, Vice President of Market Access at Celltrion USA. “Yuflyma®’s new formulary listing in Ventegra’s public and private insurance markets will expand patient access and improve quality of life.”“With Ventegra’s placement of Yuflyma® on its formulary as a biosimilar option, Celltrion is well positioned in the U.S. adalimumab market, poised for significant growth, and ready to leap forward as a global leading biopharmaceutical company,” said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. “Celltrion USA has gained strong opportunities in direct sales in the U.S. as this contract was led by Celltrion experts with extensive experience in establishing and implementing strategies that incorporate local considerations and parameters. Celltrion USA expects to continue achieving positive results in the U.S. with its extensive portfolio of products.”About Celltrion USACelltrion USA is Celltrion Healthcare’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion USA will continue to leverage Celltrion Healthcare’s unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. Celltrion Healthcare endeavors to offer high-quality, cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information, please visit: www.celltrionusa.com/About Ventegra®Ventegra®, recognized as a “New Class of Trade,” serves as a Medical Benefit Manager (“MBM”) with Pharmacy Services Administrator (“PSA”) as part of its portfolio of products. Ventegra is a single, turnkey solution for clients interested in managing their medical and pharmacy benefit services with integrity, quality, and complete transparency around data/costs of care. The Ventegra business model fundamentally realigns financial incentives focusing on value-based care and total healthcare cost. Ventegra understands the value of the coordinated care delivery model and can serve the needs of those with similar goals and objectives. www.ventegra.com
    2023-10-06
  • 5
    Celltrion USA launches Yuflyma® (adalimumab-aaty),..
    Celltrion USA launches Yuflyma® (adalimumab-aaty), a Humira® (adalimumab) biosimilar, in the United StatesYuflyma is Celltrion USA's high-concentration (100mg/mL) and citrate-free formulation of Humira® (adalimumab) biosimilar JERSEY CITY, N.J.--Celltrion USA today announced the launch of Yuflyma® (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of Humira® (adalimumab) biosimilar, providing an alternative option for patients.Yuflyma is indicated for the treatment of eight conditions, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.1First approved by the Food and Drug Administration on May 23, 2023, Yuflyma became commercially available among key distributors across the U.S. on July 2nd. Yuflyma is listed at $6,576.50 per month. Yuflyma is available in two device types — auto-injector and pre-filled syringe options.More than 80% of patients treated with Humira in the U.S. rely on a high-concentration and citrate-free formulation.2 Yuflyma is a citrate-free formulation that is highly concentrated at 100mg/mL. It also maintains stability at 25℃ (77°F) for 30 days to provide longer shelf life than Humira and is administered via a latex-free device.1“The launch of Yuflyma is a critical milestone not only for Celltrion USA, but for patients, healthcare providers, and payers,” said Tom Nusbickel, Chief Commercial Officer at Celltrion USA. “We are committed to providing a patient-centric approach with a focus on increased access to innovative, high-quality biologics in the United States. Celltrion has a demonstrated track record of commercial, regulatory and manufacturing success globally – including the first monoclonal antibody biosimilar infliximab– and our dedicated immunology commercial team is ready to leverage their experience and market knowledge in the U.S.”Professor Jonathan Kay of UMass Chan Medical School, said: “The launch of Yuflyma provides patients with one of only a few FDA-approved adalimumab biosimilars that has a high-concentration, citrate-free formulation. This formulation can reduce injection discomfort for patients with chronic conditions like rheumatoid arthritis, thereby improving adherence to treatment.”To improve patients’ and healthcare providers’ experience using Yuflyma, Celltrion USA is proud to offer Celltrion CONNECT® Patient Support Program along with Celltrion CARES™ Co-pay Assistance Program beginning July 10th. The Patient Support Program for Yuflyma will provide benefits verification, prior authorization assistance, and co-pay assistance. Eligible patients with private/commercial insurance may receive Yuflyma for as little as $0 out of pocket per month. Patients who are uninsured or underinsured may be eligible to receive Yuflyma through the Celltrion CONNECT® Patient Assistance Program (PAP). Nurses will be available to answer patient questions and provide training. Visit www.CelltrionConnect.com to learn more.Celltrion is seeking an interchangeability designation from the U.S. FDA for Yuflyma, tentatively expected Q4 in 2024.Notes to Editors:About Yuflyma® (CT-P17, biosimilar adalimumab-aaty)1Yuflyma was the world’s first proposed high-concentration, low-volume and citrate-free adalimumab biosimilar to receive European Commission approval in Europe. Yuflyma is FDA approved for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and Hidradenitis Suppurativa. Yuflyma is a recombinant fully human anti–tumour necrosis factor α (anti-TNFα) monoclonal antibody. Following the launch of 40mg/0.4mL, in the U.S. in July 2023, Celltrion additionally plans to launch two different types of dosage forms 80mg/0.8mL, 20mg/0.2mL. To learn more about Yuflyma, please visit https://www.celltrionusa.com/.About InterchangeabilityAn interchangeable biosimilar product is a biosimilar that meets additional requirements outlined by law, and often require additional clinical studies, which demonstrate that there is no additional risk or reduced drug effectiveness if a patient switches back and forth between an interchangeable biosimilar and a reference product, as compared to receiving treatment with just the reference product. When a biosimilar receives an interchangeability designation by the FDA, that means the biosimilar product may be substituted for the reference product without the prescriber having to change the prescription. The substitution may occur at the pharmacy, subject to state pharmacy laws which vary by state, a practice commonly called “pharmacy-level substitution” — similar to how generic drugs are substituted for brand name drugs.Yuflyma® IMPORTANT SAFETY INFORMATIONSERIOUS INFECTIONSPatients treated with YUFLYMA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.Discontinue YUFLYMA if a patient develops a serious infection or sepsis.Reported infections include:Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before YUFLYMA use and during therapy. Initiate treatment for latent TB prior to YUFLYMA use.Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric antifungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.Carefully consider the risks and benefits of treatment with YUFLYMA prior to initiating therapy in patients with chronic or recurrent infection.Monitor patients closely for the development of signs and symptoms of infection during and after treatment with YUFLYMA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.Treatment with YUFLYMA should not be initiated in patients with an active infection, including localized infections.Patients over 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants (such as corticosteroids or methotrexate), may be at greater risk of infection. Discontinue YUFLYMA if a patient develops a serious infection or sepsis. For a patient who develops a new infection during treatment with YUFLYMA, closely monitor them, perform a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and initiate appropriate antimicrobial therapy.Drug interactions with biologic products: In clinical studies in patients with RA, an increased risk of serious infections has been observed with the combination of TNF blockers with anakinra or abatacept, with no added benefit; therefore, use of YUFLYMA with abatacept or anakinra is not recommended in patients with RA. A higher rate of serious infections has also been observed in patients with RA treated with rituximab who received subsequent treatment with a TNF blocker. There is insufficient information regarding the concomitant use of YUFLYMA and other biologic products for the treatment of RA, PsA, AS, CD, UC, PS, and HS. Concomitant administration of YUFLYMA with other biologic DMARDS (e.g., anakinra and abatacept) or other TNF blockers is not recommended based upon the possible increased risk for infections and other potential pharmacological interactions. A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker.MALIGNANCYLymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab products.Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.Consider the risks and benefits of TNF blocker treatment including YUFLYMA prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC), or when considering continuing a TNF blocker in patients who develop a malignancy.In controlled portions of clinical trials of some adalimumab products, more cases of malignancies have been observed compared to control-treated adult patients.Non-melanoma skin cancer (NMSC) was reported during clinical trials for patients treated with adalimumab products. During the controlled portions of 39 global adalimumab clinical trials in adult patients with RA, PsA, AS, CD, UC, PS and HS, the rate (95% confidence interval) of NMSC was 0.8 (0.52, 1.09) per 100 patient-years among adalimumab-treated patients and 0.2 (0.10, 0.59) per 100 patient-years among control-treated patients. Examine all patients, particularly those with a medical history of prior prolonged immunosuppressant therapy or psoriasis patients with a history of PUVA treatment, for the presence of NMSC prior to and during treatment with YUFLYMA.In clinical trials of some adalimumab products, there was an approximate threefold higher rate of lymphoma than expected in the general U.S. population. Patients with RA and other chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at a higher risk (up to several fold) than the general population for the development of lymphoma, even in the absence of TNF blockers.Postmarketing cases of acute and chronic leukemia were reported with use of a TNF blocker in RA and other indications. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving adalimumab were lymphomas; other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents.HYPERSENSITIVITYAnaphylaxis and angioneurotic edema have been reported following administration of adalimumab products. If an anaphylactic or other serious allergic reaction occurs, immediately discontinue administration of YUFLYMA and institute appropriate therapy.HEPATITIS B VIRUS REACTIVATIONUse of TNF blockers, including YUFLYMA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. In some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal.Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy.Exercise caution in prescribing TNF blockers for patients identified as carriers of HBV and closely monitor such patients for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy.In patients who develop HBV reactivation, stop YUFLYMA and initiate effective antiviral therapy with appropriate supportive treatment. The safety of resuming TNF blocker therapy after HBV reactivation is controlled is not known. Therefore, exercise caution when considering resumption of YUFLYMA therapy in this situation and monitor patients closely.NEUROLOGIC REACTIONSUse of TNF blocking agents, including adalimumab products, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis (MS) and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome.Exercise caution in considering the use of YUFLYMA in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of YUFLYMA should be considered if any of these disorders develop.There is a known association between intermediate uveitis and central demyelinating disorders.HEMATOLOGIC REACTIONSRare reports of pancytopenia including aplastic anemia have been reported with TNF blocking agents.Adverse reactions of the hematologic system, including medically significant cytopenia, have been infrequently reported with adalimumab products.Consider discontinuation of YUFLYMA therapy in patients with confirmed significant hematologic abnormalities.HEART FAILURECases of worsening congestive heart failure (CHF) and new-onset CHF have been reported with TNF blockers. Cases of worsening CHF have also been observed with adalimumab products.Exercise caution when using YUFLYMA in patients who have heart failure and monitor them carefully.AUTOIMMUNITYTreatment with adalimumab products may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with YUFLYMA, discontinue treatment.IMMUNIZATIONSPatients on YUFLYMA may receive concurrent vaccinations, except for live vaccines.It is recommended that pediatric patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating YUFLYMA therapy.No data are available on the secondary transmission of infection by live vaccines in patients receiving adalimumab products.The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants.ADVERSE REACTIONSThe most common adverse reactions in adalimumab clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.INDICATIONSYUFLYMA is a tumor necrosis factor (TNF) blocker indicated for:Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RAJuvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and olderPsoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsAAnkylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active ASCrohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and olderUlcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adultsLimitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockersPlaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriateHidradenitis Suppurativa (HS): treatment of adult patients with moderate to severe hidradenitis suppurativaPlease see full Prescribing Information for Yuflyma® (adalimumab-aaty)About Celltrion HealthcareCelltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA Current Good Manufacturing Practice (cGMP) and the EU GMP guidelines. Celltrion Healthcare endeavors to offer high-quality, cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information, please visit: https://www.celltrionhealthcare.com/en-us.About Celltrion USACelltrion USA is Celltrion Healthcare’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion currently has five biosimilars approved by the U.S. FDA: Inflectra® (infliximab-dyyb), Truxima® (rituximab-abbs), Herzuma® (trastuzumab-pkrb), Vegzelma® (bevacizumab-adcd), and Yuflyma®(adalimumab-aaty). Celltrion USA will continue to leverage Celltrion Healthcare’s unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients.FORWARD-LOOKING STATEMENTCertain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion/Celltrion Healthcare that may constitute forward-looking statements, under pertinent securities laws.These statements may be identified by words such as “prepares”, “hopes to”, “upcoming”, ”plans to”, “aims to”, “to be launched”, “is preparing, “once gained”, “could”, “with the aim of”, “may”, “once identified”, “will”, “working towards”, “is due”, “become available”, “has potential to”, the negative of these words or such other variations thereon or comparable terminology.In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion/Celltrion Healthcare's management, of which many are beyond its control.Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.Such Risks and uncertainties may include, among other things, uncertainties regarding the launch timing and commercial success of Celltrion in the United States; the uncertainties inherent in supply chain, manufacturing, research and development, and the possibility of unfavorable new clinical data and further analyses of existing clinical data as it relates to Celltrion products; intellectual property and/or litigation/settlement implications; decisions by the FDA impacting labeling, manufacturing processes, safety, promotion, and/or other matters that could affect the availability or commercial potential of Celltrion products; and uncertainties regarding access challenges for our biosimilar products where our product may not receive appropriate formulary access or remains in a disadvantaged position relative to competitive products; and competitive developments. A further description of risks and uncertainties can be found in Celltrion's Annual Report.Although forward-looking statements contained in this presentation are based upon what management of Celltrion/Celltrion Healthcare believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion/Celltrion Healthcare undertakes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.TrademarksHumira is a registered trademark of AbbVie.Yuflyma® is a registered trademark of Celltrion, Inc., used under license.References1 Yuflyma US prescribing information (2023)2 Symphony Health, IQVIA
    2023-10-05
  • 4
    Celltrion USA Announces U.S. FDA Approval of Yufly..
    Celltrion USA Announces U.S. FDA Approval of Yuflyma® (adalimumab-aaty), a High-Concentration and Citrate-Free Formulation of Humira® (adalimumab) BiosimilarYuflyma is FDA approved to treat eight conditions including Crohn’s disease and ulcerative colitisYuflyma is the first high-concentration and citrate-free adalimumab biosimilar to gain EU marketing authorizationYuflyma offers citrate-free and high-concentration adalimumab formulation, providing an alternative treatment option for patients JERSEY CITY, N.J.--(BUSINESS WIRE)--Celltrion USA today announced that the U.S. Food and Drug Administration (FDA) has approved Yuflyma® (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of Humira® (adalimumab) biosimilar. The FDA granted approval for the treatment of eight conditions: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.1Yuflyma is Celltrion’s fifth biosimilar and second anti-TNF biosimilar approved for use in the United States. Yuflyma will offer patients pre-filled syringe and autoinjector administration options to meet different preferences and needs.“Yuflyma offers patients a high-concentration and citrate-free formulation of adalimumab biosimilar, providing an alternative treatment option for patients. It represents a key treatment option in patient care and patient choice,” said Tom Nusbickel, Chief Commercial Officer at Celltrion USA. “As a leading global biopharmaceutical company, we are leveraging our unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to expand the availability of high-quality biosimilars for U.S. patients.”“Currently, more than 80% of patients treated with Humira in the United States rely on a high-concentration and citrate-free formulation of this medication. The availability of a high-concentration and citrate-free formulation adalimumab biosimilar provides an important treatment option for patients with inflammatory diseases who benefit from this effective therapy,” said Professor Jonathan Kay of UMass Chan Medical School.The approval of Yuflyma was based on a comprehensive data package of analytical, preclinical, and clinical studies, demonstrating that Yuflyma is comparable to the reference product in terms of efficacy, safety, pharmacokinetics, and immunogenicity up to 24 weeks and one year following treatment.2,3,4Yuflyma will be available to patients in the U.S. starting July 2023.Celltrion is also seeking an interchangeability designation from the U.S. FDA for Yuflyma, which is tentatively expected Q4 2024.Notes to Editors:About Yuflyma® (CT-P17, biosimilar adalimumab-aaty)1Yuflyma was the world’s first proposed high-concentration, low-volume and citrate-free adalimumab biosimilar to receive European Commission approval in Europe. Yuflyma is FDA approved for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and Hidradenitis Suppurativa. Yuflyma is a recombinant fully human anti–tumour necrosis factor α (anti-TNFα) monoclonal antibody. Following the launch of 40mg/0.4mL, in the U.S. in July 2023, Celltrion additionally plans to launch two different types of dosage forms 80mg/0.8mL, 20mg/0.2mL.About InterchangeabilityAn interchangeable biosimilar product is a biosimilar that meets additional requirements outlined by law, and often require additional clinical studies, which demonstrate that there is no additional risk or reduced drug effectiveness if a patient switches back and forth between an interchangeable biosimilar and a reference product, as compared to receiving treatment with just the reference product. When a biosimilar receives an interchangeability designation by the FDA, that means the biosimilar product may be substituted for the reference product without the prescriber having to change the prescription. The substitution may occur at the pharmacy, subject to state pharmacy laws which vary by state, a practice commonly called “pharmacy-level substitution” — similar to how generic drugs are substituted for brand name drugs.Yuflyma® IMPORTANT SAFETY INFORMATION1SERIOUS INFECTIONSPatients treated with YUFLYMA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.Discontinue YUFLYMA if a patient develops a serious infection or sepsis.Reported infections include:Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before YUFLYMA use and during therapy. Initiate treatment for latent TB prior to YUFLYMA use.Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric antifungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.Carefully consider the risks and benefits of treatment with YUFLYMA prior to initiating therapy in patients with chronic or recurrent infection.Monitor patients closely for the development of signs and symptoms of infection during and after treatment with YUFLYMA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.Treatment with YUFLYMA should not be initiated in patients with an active infection, including localized infections.Patients over 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants (such as corticosteroids or methotrexate), may be at greater risk of infection. Discontinue YUFLYMA if a patient develops a serious infection or sepsis. For a patient who develops a new infection during treatment with YUFLYMA, closely monitor them, perform a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and initiate appropriate antimicrobial therapy.Drug interactions with biologic products: In clinical studies in patients with RA, an increased risk of serious infections has been observed with the combination of TNF blockers with anakinra or abatacept, with no added benefit; therefore, use of YUFLYMA with abatacept or anakinra is not recommended in patients with RA. A higher rate of serious infections has also been observed in patients with RA treated with rituximab who received subsequent treatment with a TNF blocker. There is insufficient information regarding the concomitant use of YUFLYMA and other biologic products for the treatment of RA, PsA, AS, CD, UC, PS, and HS. Concomitant administration of YUFLYMA with other biologic DMARDS (e.g., anakinra and abatacept) or other TNF blockers is not recommended based upon the possible increased risk for infections and other potential pharmacological interactions. A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker.MALIGNANCYLymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab products. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.Consider the risks and benefits of TNF blocker treatment including YUFLYMA prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC), or when considering continuing a TNF blocker in patients who develop a malignancy.In controlled portions of clinical trials of some adalimumab products, more cases of malignancies have been observed compared to control-treated adult patients.Non-melanoma skin cancer (NMSC) was reported during clinical trials for patients treated with adalimumab products. During the controlled portions of 39 global adalimumab clinical trials in adult patients with RA, PsA, AS, CD, UC, PS and HS, the rate (95% confidence interval) of NMSC was 0.8 (0.52, 1.09) per 100 patient-years among adalimumab-treated patients and 0.2 (0.10, 0.59) per 100 patient-years among control-treated patients. Examine all patients, particularly those with a medical history of prior prolonged immunosuppressant therapy or psoriasis patients with a history of PUVA treatment, for the presence of NMSC prior to and during treatment with YUFLYMA.In clinical trials of some adalimumab products, there was an approximate threefold higher rate of lymphoma than expected in the general U.S. population. Patients with RA and other chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at a higher risk (up to several fold) than the general population for the development of lymphoma, even in the absence of TNF blockers.Postmarketing cases of acute and chronic leukemia were reported with use of a TNF blocker in RA and other indications. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving adalimumab were lymphomas; other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents.HYPERSENSITIVITYAnaphylaxis and angioneurotic edema have been reported following administration of adalimumab products. If an anaphylactic or other serious allergic reaction occurs, immediately discontinue administration of YUFLYMA and institute appropriate therapy.HEPATITIS B VIRUS REACTIVATIONUse of TNF blockers, including YUFLYMA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. In some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal.Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy.Exercise caution in prescribing TNF blockers for patients identified as carriers of HBV and closely monitor such patients for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy.In patients who develop HBV reactivation, stop YUFLYMA and initiate effective antiviral therapy with appropriate supportive treatment. The safety of resuming TNF blocker therapy after HBV reactivation is controlled is not known. Therefore, exercise caution when considering resumption of YUFLYMA therapy in this situation and monitor patients closely.NEUROLOGIC REACTIONSUse of TNF blocking agents, including adalimumab products, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis (MS) and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome.Exercise caution in considering the use of YUFLYMA in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of YUFLYMA should be considered if any of these disorders develop.There is a known association between intermediate uveitis and central demyelinating disorders.HEMATOLOGIC REACTIONSRare reports of pancytopenia including aplastic anemia have been reported with TNF blocking agents.Adverse reactions of the hematologic system, including medically significant cytopenia, have been infrequently reported with adalimumab products.Consider discontinuation of YUFLYMA therapy in patients with confirmed significant hematologic abnormalities.HEART FAILURECases of worsening congestive heart failure (CHF) and new-onset CHF have been reported with TNF blockers. Cases of worsening CHF have also been observed with adalimumab products.Exercise caution when using YUFLYMA in patients who have heart failure and monitor them carefully.AUTOIMMUNITYTreatment with adalimumab products may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with YUFLYMA, discontinue treatment.IMMUNIZATIONSPatients on YUFLYMA may receive concurrent vaccinations, except for live vaccines.It is recommended that pediatric patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating YUFLYMA therapy.No data are available on the secondary transmission of infection by live vaccines in patients receiving adalimumab products.The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants.ADVERSE REACTIONSThe most common adverse reactions in adalimumab clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.INDICATIONSYUFLYMA is a tumor necrosis factor (TNF) blocker indicated for:Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RAJuvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and olderPsoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsAAnkylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active ASCrohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and olderUlcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adultsLimitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockersPlaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriateHidradenitis Suppurativa (HS): treatment of adult patients with moderate to severe hidradenitis suppurativaPlease see full Prescribing Information for Yuflyma® (adalimumab-aaty)About Celltrion HealthcareCelltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA Current Good Manufacturing Practice (cGMP) and the EU GMP guidelines. Celltrion Healthcare endeavors to offer high-quality, cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information, please visit: https://www.celltrionhealthcare.com/en-us.About Celltrion USACelltrion USA is Celltrion Healthcare’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion currently has five biosimilars approved by the U.S. FDA: Inflectra® (infliximab-dyyb), Truxima® (rituximab-abbs), Herzuma® (trastuzumab-pkrb), Vegzelma® (bevacizumab-adcd), and Yuflyma®(adalimumab-aaty). Celltrion USA will continue to leverage Celltrion Healthcare’s unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients.FORWARD-LOOKING STATEMENTCertain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion/Celltrion Healthcare that may constitute forward-looking statements, under pertinent securities laws.These statements may be identified by words such as “prepares”, “hopes to”, “upcoming”, ”plans to”, “aims to”, “to be launched”, “is preparing, “once gained”, “could”, “with the aim of”, “may”, “once identified”, “will”, “working towards”, “is due”, “become available”, “has potential to”, the negative of these words or such other variations thereon or comparable terminology.In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion/Celltrion Healthcare's management, of which many are beyond its control.Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.Such Risks and uncertainties may include, among other things, uncertainties regarding the launch timing and commercial success of Celltrion in the United States; the uncertainties inherent in supply chain, manufacturing, research and development, and the possibility of unfavorable new clinical data and further analyses of existing clinical data as it relates to Celltrion products; intellectual property and/or litigation/settlement implications; decisions by the FDA impacting labeling, manufacturing processes, safety, promotion, and/or other matters that could affect the availability or commercial potential of Celltrion products; and uncertainties regarding access challenges for our biosimilar products where our product may not receive appropriate formulary access or remains in a disadvantaged position relative to competitive products; and competitive developments. A further description of risks and uncertainties can be found in Celltrion's Annual Report.Although forward-looking statements contained in this presentation are based upon what management of Celltrion/Celltrion Healthcare believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion/Celltrion Healthcare undertakes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.TrademarksHumira is a registered trademark of AbbVie.Yuflyma® is a registered trademark of Celltrion, Inc., used under license.References1 Yuflyma US prescribing information (2023)2 Yu K et al., Pharmacokinetic Equivalence of CT‐P17 to High‐Concentration (100 mg/mL) Reference Adalimumab: A Randomized Phase I Study in Healthy Subjects. Clin Transl Sci. 2021;14:1280-91.3 Kay J et al., Efficacy and safety of biosimilar CT-P17 versus reference adalimumab in subjects with rheumatoid arthritis: 24-week results from a randomized study. Arthritis Res Ther. 2021;23(1):51.4 Furst D et al., Efficacy and safety of switching from reference adalimumab to CT-P17 (100 mg/ml): 52-week randomised study in rheumatoid arthritis. Rheumatology. 2022;61(3):1385-95.
    2023-10-05
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    Celltrion USA Appoints Thomas Nusbickel as Chief C..
     Celltrion USA Appoints Thomas Nusbickel as Chief Commercial Officer Seasoned commercial operations executive brings three decades of global biopharmaceutical industry experience to Celltrion USA’s leadership team February 06, 2023, CHICAGO, IL –Celltrion USA, a global leader in expanding access to innovative biologics, today announced the appointment of Thomas Nusbickel as Chief Commercial Officer.  Mr. Nusbickel will oversee the company’s commercial operations and play a key role inexpanding access to Celltrion’s rapidly growing portfolio of innovative biologics in the United States. Mr. Nusbickel’s commercial experience includes more than 30 years in the biopharmaceutical industry, with extensive experience launching and expanding access to pharmaceuticals across multiple therapeutic areas including oncology and immunology. Mr. Nusbickel brings deep experience in the biosimilar space from previous roles, where he championedaffordable access to biosimilars as Vice President Access and Government Affairs at Coherus BioSciences andbuilt an industry-leading account sales and market access team to support product launches as Head of U.S. Market Access for Biosimilars at Pfizer company. He also brings more than 20 years of experience in value access and advocacy and global marketing serving in senior executive roles at Amgen.  Mr. Nusbickel holds a master’s degree in business administration from Pepperdine University and a bachelor’s degree in biology from Eckerd College. “I’m honored to take on this new role as chief commercial officer of Celltrion USA and join a mission-driven company delivering innovative biologics to improve care for U.S. patients,” said Mr. Nusbickel. “I look forward to leveraging my experience in the biopharmaceutical field to build on a solid pathway to deliver long-term growth for the company. Together with my colleagues, we will bring a growing pipeline of innovative treatments including Vegzelma®(biosimilar bevacizumab), Yuflyma™(biosimilar adalimumab) and a novel subcutaneous formulation of infliximab.” “This year will be a landmark year for biosimilars and Celltrion USA is prepared for an exciting future ahead as we continue to drive strategic growth to address unmet medical needs for patients in the United States,” said Hyoung Ki Kim, Vice-Chairman & CEO at Celltrion Healthcare.. “We are thrilled to welcome Thomas Nusbickel to our leadership team at this critical time.” Notes to Editors:  About Celltrion HealthcareCelltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed, and built to comply with the US FDA Current Good Manufacturing Practice (cGMP) and the EU GMP guidelines. Celltrion Healthcare endeavors to offer high-quality, cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information, please visit: https://www.celltrionhealthcare.com/en-us. About Celltrion USACelltrion USA is Celltrion Healthcare’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion currently has four biosimilars approved by the U.S. FDA:Inflectra® (infliximab), Truxima®(rituximab), Herzuma®(trastuzumab), and Vegzelma®(bevacizumab).  Celltrion USA will continue toleverage Celltrion Healthcare’s unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. FORWARD-LOOKING STATEMENTCertain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion/Celltrion Healthcare that may constitute forward-looking statements, under pertinent securities laws.These statements may be identified by words such as “prepares”, “hopes to”, “upcoming”, ”plans to”, “aims to”, “to be launched”, “is preparing, “once gained”, “could”, “with the aim of”, “may”, “once identified”, “will”, “working towards”, “is due”, “become available”, “has potential to”, the negative of these words or such other variations thereon or comparable terminology.In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion/Celltrion Healthcare's management, of which many are beyond its control.Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.Although forward-looking statements contained in this presentation are based upon what management of Celltrion/Celltrion Healthcare believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion/Celltrion Healthcare undertakes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.
    2023-10-05
  • 2
    Celltrion USA announces submission of the Biologic..
    Celltrion USA announces submission of the Biologics License Application (BLA) of novel subcutaneous formulation of CT-P13 to U.S. Food and Drug Administration  CT-P13 SC is a novel subcutaneous formulation of infliximabThe Biologics License Application (BLA) submission is based on phase III pivotal data that evaluated the efficacy and safety of CT-P13 SC as maintenance therapy in patients with moderately to severely active ulcerative colitis and Crohn’s diseaseCelltrion’s CT-P13 is the first and only infliximab to have both intravenous (IV) and subcutaneous (SC) formulations; novel formulation provides an alternative administration option for physicians and their patients in the U.S.December 22, 2022 06:21 PM Eastern Standard Time  CHICAGO--(BUSINESS WIRE)--Celltrion USA today announced the submission of a Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act (a “stand-alone” BLA) for lead product candidate, CT-P13 SC, which is the subcutaneous formulation of infliximab to the U.S. Food and Drug Administration (FDA). The planned initial submission package will seek approval of CT-P13 SC for the treatment of inflammatory bowel disease (IBD).“This BLA submission marks a significant milestone for Celltrion and we are working with the FDA to bring this innovative treatment to the U.S. market,” said Hyoung Ki Kim, Vice Chairman & CEO, Celltrion Healthcare. “We are committed to furthering the advancement of innovative treatments that provide improvements to clinical outcomes and drug pharmacology and reduce patients’ burden on their day-to-day lives.”The submission is based on results from the phase III pivotal data that evaluated the efficacy and safety of CT-P13 SC as maintenance therapy in patients with moderate to severe active ulcerative colitis (UC) (LIBERTY-UC) and Crohn’s disease (CD) (LIBERTY-CD). Based on the results of the LIBERTY-UC and LIBERTY-CD studies, CT-P13 SC demonstrated superiority over placebo in maintenance therapy after induction therapy of intravenous formulation of infliximab in patients with UC and CD respectively, over a one-year treatment period.1,2A subcutaneous formulation has the potential to enhance treatment options for the use of the infliximab drug by providing high consistency in drug exposure and a convenient method of administration.3,4“We’re excited about the potential of CT-P13 SC as it allows patients to have more control of their treatment, providing much better independence and convenience,” said Jaeik Shim, Chief Operating Officer, Celltrion USA. “In addition, CT-P13 SC releases the burden of having to travel to treatment for IV infusions, reducing treatment-related travel costs for patients and caregivers.”Notes to Editors:About the pivotal LIBERTY-UC studyThe LIBERTY-UC is a randomized, placebo-controlled, double-blind, phase III study designed to evaluate the superiority of the subcutaneous CT-P13 (CT-P13 SC) in efficacy and safety during maintenance therapy in patient with moderate to severe active UC. A total of 438 patients were randomized at Week 10. The rate of clinical remission at Week 54 was significantly greater in CT- P13 SC (43.2%) compared to placebo (20.8%) (P<0.0001). The safety profile during maintenance phase was generally comparable between CT-P13 SC and placebo arms.About the pivotal LIBERTY-CD studyThe LIBERTY-CD is a randomized, placebo-controlled, double-blind, phase III study designed to evaluate the superiority of the subcutaneous CT-P13 (CT-P13 SC) in efficacy and safety during maintenance therapy in patient with moderate to severe active CD. A total of 343 patients were randomized at Week 10. At Week 54, the clinical remission rate was greater in CT-P13 SC arm than placebo arm (62.3% and 32.1% respectively, with P <0.0001). The safety profile during maintenance phase was generally comparable between CT-P13 SC and placebo arms.About subcutaneous (SC) injection of CT-P13CT-P13 SC is the world’s first subcutaneous formulation of infliximab. A 120 mg fixed dose of CT-P13 SC has been approved for use in the European Union (EU), in adults regardless of body weight, in both existing and newly added indications. The SC formulation has the potential to enhance treatment options for the use of the infliximab drug by providing high consistency in drug exposure and a convenient method of administration.3,4About Celltrion HealthcareCelltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed, and built to comply with the US FDA Current Good Manufacturing Practice (cGMP) and the EU GMP guidelines. Celltrion Healthcare endeavors to offer high-quality, cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information, please visit: https://www.celltrionhealthcare.com/en-us.About Celltrion USACelltrion USA is Celltrion Healthcare’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to next-generation biopharmaceuticals to improve care for U.S. patients. Celltrion currently has four biosimilars approved by the U.S. FDA: Remsima® (infliximab), Truxima® (rituximab), Herzuma® (trastuzumab), and Vegzelma® (bevacizumab). Celltrion USA will continue to leverage Celltrion Healthcare’s unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients.FORWARD-LOOKING STATEMENTCertain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion/Celltrion Healthcare that may constitute forward-looking statements, under pertinent securities laws.These statements may be identified by words such as “prepares”, “hopes to”, “upcoming”, ”plans to”, “aims to”, “to be launched”, “is preparing, “once gained”, “could”, “with the aim of”, “may”, “once identified”, “will”, “working towards”, “is due”, “become available”, “has potential to”, the negative of these words or such other variations thereon or comparable terminology.In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion/Celltrion Healthcare's management, of which many are beyond its control.Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.Although forward-looking statements contained in this presentation are based upon what management of Celltrion/Celltrion Healthcare believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion/Celltrion Healthcare undertakes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.References1 CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (LIBERTY-UC). Clinicaltrials.gov;2022. https://clinicaltrials.gov/ct2/show/NCT04205643#wrapper [Last Accessed December 2022]2 CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD). Clinicaltrials.gov;2022. https://clinicaltrials.gov/ct2/show/NCT03945019 [Last Accessed December 2022]3 Reinisch W et al. DOP62 A novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: 1-year result from a Phase I open-label randomised controlled trial in patients with active Crohn’s disease, Journal of Crohn's and Colitis, Volume 13, Issue Supplement_1, March 2019, Pages S066–S067, https://doi.org/10.1093/ecco-jcc/jjy222.0964 Westhovens R, Wiland P, Zawadzki M et al. A Novel Formulation of CT-P13 (Infliximab Biosimilar) for Subcutaneous Administration: 30-week Results from Part Two of a Phase I/III Randomised Controlled Trial in Patients with Rheumatoid Arthritis. Poster (SAT0170) Presented at EULAR 2019.
    2023-10-05
  • 1
    Celltrion USA receives U.S. FDA approval for its o..
    Celltrion USA Receives U.S. FDA Approval for its Oncology Biosimilar Vegzelma® (bevacizumab-adcd) for the Treatment of Six Types of CancerVegzelma® is Celltrion’s third oncology biosimilar to receive approval from the U.S. FDAVegzelma® offers U.S. patients living with multiple types of cancer a new, safe, and effective treatment optionThe approval is based on totality of evidence with no clinically meaningful differences in efficacy or safety with the reference product Avastin® (bevacizumab) September 28, 2022 06:01 AM Eastern Daylight TimeCHICAGO--(BUSINESS WIRE)--Celltrion USA today announced that the U.S. Food and Drug Administration (FDA) has approved Vegzelma® (bevacizumab-adcd), a biosimilar to Avastin® (bevacizumab)1, for the treatment of six types of cancer: metastatic colorectal cancer; recurrent or metastatic non-squamous non-small cell lung cancer (nsNSCLC); recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent, or metastatic cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer.“Biosimilars have been used in many disease areas including oncology, and have shown to be safe and effective while lowering the drug cost and increasing the access to more patients around the world,” said Professor Claire Verschraegen, Director of the Division of Medical Oncology at the Ohio State University Comprehensive Cancer Center, Columbus, OH. “With the availability of biosimilars such as Vegzelma® in the U.S., oncologists will have additional treatment options for patients across multiple cancer types.”The FDA approval of Vegzelma® was based on the totality of evidence, including the pivotal phase III trial in patients with metastatic or recurrent nsNSCLC. Results showed that as a first-line treatment, Vegzelma® is highly similar to the reference product in terms of efficacy, safety and pharmacokinetics.2“The approval of Vegzelma® is an important milestone in the U.S. which adds to our growing portfolio of oncology treatments and marks an important step forward in expanding access to cancer care,” said Jaeik Shim, Chief Operating Officer at Celltrion USA. “As a leading force in the global biopharmaceutical industry, we look forward to working with payers and providers to make our product available to patients. With our high-quality and affordable biosimilar medicines, we plan to strengthen our presence in the U.S. and contribute to a more sustainable healthcare system for the future.”Vegzelma® is Celltrion’s third oncology biosimilar approved for use in the U.S., following the approval of Truxima® (rituximab-abbs) and Herzuma® (trastuzumab-pkrb). Vegzelma® was approved in the EU in August 2022 and UK and Japan in September 2022. Regulatory reviews are ongoing in additional countries.- ENDS -Notes to Editors:About Vegzelma® (CT-P16, biosimilar bevacizumab-adcd)2Vegzelma® is an anti-cancer monoclonal antibody treatment biosimilar to Avastin® (bevacizumab). Vegzelma® is a recombinant humanized monoclonal antibody which binds to vascular endothelial growth factor (VEGF), the key driver of vasculogenesis and angiogenesis, and thereby inhibits the binding of VEGF to its receptors Flt-1 (VEGFR-1), and kinase insert domain receptor (KDR) (VEGFR-2), on the surface of endothelial cells. In the U.S., Vegzelma® is indicated for the treatment of patients with metastatic colorectal cancer (mCRC); recurrent or metastatic non-squamous non-small cell lung cancer (nsNSCLC); recurrent glioblastoma (GBM); metastatic renal cell carcinoma (mRCC); persistent, recurrent, or metastatic cervical cancer (CC); epithelial ovarian, fallopian tube, or primary peritoneal cancer.Vegzelma® Important Safety Information3Warnings and PrecautionsGastrointestinal Perforations and Fistula: Discontinue for gastrointestinal perforations, tracheoesophageal fistula, grade 4 fistula, or fistula formation involving any organ.Surgery and Wound Healing Complications: In patients who experience wound healing complications during VEGZELMA treatment, withhold VEGZELMA until adequate wound healing. Withhold for at least 28 days prior to elective surgery. Do not administer VEGZELMA for at least 28 days following a major surgery, and until adequate wound healing. The safety of resumption of bevacizumab products after resolution of wound healing complication has not been established. Discontinue for wound healing complication of necrotizing fasciitis.Hemorrhage: Severe or fatal hemorrhages have occurred. Do not administer for recent hemoptysis. Discontinue for Grade 3-4 hemorrhage.Arterial Thromboembolic Events (ATE): Discontinue for severe ATE.Venous Thromboembolic Events (VTE): Discontinue for Grade 4 VTE.Hypertension: Monitor blood pressure and treat hypertension. Withhold if not medically controlled; resume once controlled. Discontinue for hypertensive crisis or hypertensive encephalopathy.Posterior Reversible Encephalopathy Syndrome (PRES): Discontinue.Renal Injury and Proteinuria: Monitor urine protein. Discontinue for nephrotic syndrome. Withhold until less than 2 grams of protein in urine.Infusion-Related Reactions: Decrease rate for infusion-related reactions. Discontinue for severe infusion-related reactions and administer medical therapy.Embryo-Fetal Toxicity: May cause fetal harm. Advise females of potential risk to fetus and need for use of effective contraception.Ovarian Failure: Advise females of the potential risk.Congestive Heart Failure (CHF): Discontinue VEGZELMA in patients who develop CHF.Pregnancy WarningBased on findings from animal studies and their mechanism of action, bevacizumab products may cause fetal harm in pregnant women. Limited postmarketing reports describe cases of fetal malformations with use of bevacizumab products in pregnancy; however, these reports are insufficient to determine drug-associated risks. In animal reproduction studies, intravenous administration of bevacizumab to pregnant rabbits every 3 days during organogenesis at doses approximately 1 to 10 times the clinical dose of 10 mg/kg produced fetal resorptions, decreased maternal and fetal weight gain and multiple congenital malformations including corneal opacities and abnormal ossification of the skull and skeleton including limb and phalangeal defects. Furthermore, animal models link angiogenesis and VEGF and VEGFR2 to critical aspects of female reproduction, embryo-fetal development, and postnatal development. Advise pregnant women of the potential risk to a fetus.In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.Most Frequently Observed Adverse ReactionsMost common adverse reactions incidence (incidence > 10%) are epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, hemorrhage, lacrimation disorder, back pain and exfoliative dermatitis.Please see full Prescribing Information for VEGZELMA® (bevacizumab-adcd)About Celltrion HealthcareCelltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA Current Good Manufacturing Practice (cGMP) and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us.About Celltrion USACelltrion USA is Celltrion Healthcare’s U.S. subsidiary dedicated to the distribution of Celltrion’s small molecule pharmaceutical products and biosimilar products within the U.S. Celltrion USA started its business as a brand and generic pharmaceutical product distributor and expanded its portfolio to COVID-19 test kits. Celltrion USA will be dedicating its resources to biosimilar product launches in the U.S.FORWARD-LOOKING STATEMENTCertain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion/Celltrion Healthcare that may constitute forward-looking statements, under pertinent securities laws.These statements may be identified by words such as “prepares”, “hopes to”, “upcoming”, ”plans to”, “aims to”, “to be launched”, “is preparing, “once gained”, “could”, “with the aim of”, “may”, “once identified”, “will”, “working towards”, “is due”, “become available”, “has potential to”, the negative of these words or such other variations thereon or comparable terminology.In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion/Celltrion Healthcare's management, of which many are beyond its control.Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.Although forward-looking statements contained in this presentation are based upon what management of Celltrion/Celltrion Healthcare believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion/Celltrion Healthcare undertakes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.References1 Avastin is a registered trademark of Genentech Inc.2 Ohe Y et al., Randomized Phase III Study Comparing the Efficacy and Safety of CT-P16, a New Biosimilar, to Reference Bevacizumab (Avastin®) In Patients With Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC). Proceedings: American Association for Cancer Research (AACR) Annual Meeting 2022; April 8-13, 2022 New Orleans, Louisiana.3 Vegzelma US prescribing information (2022)
    2023-10-05

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