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Our latest company updates, product launches, leadership announcements, and public statements.
Recent highlights
Celltrion announces U.S. availability of AVTOZMA® (tocilizumab-anoh) subcutaneous (SC) formulation
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Celltrion USA announces incorporation of adalimumab-aaty, a Humira® biosimilar, to the Costco Member Prescription Program
– Adalimumab-aaty was first approved by the Food and Drug Administration on May 23, 2023 and became commercially available among key distributors across the U.S. on July 2, 2023- Adalimumab-aaty’s inclusion creates greater accessibility to treatments for Americans with inflammatory conditionsJERSEY CITY, N.J., Aug. 12, 2024 – Celltrion USA, Inc., (Celltrion USA) today announced its FDA-approved biosimilar adalimumab-aaty, […]
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ZYMFENTRA™ (infliximab-dyyb) demonstrated long-term efficacy and safety profile of maintenance treatment through two years for adults with moderately to severely active Crohn's disease and ulcerative colitis
– Findings from the extended LIBERTY studies and associated post-hoc analysis support the long-term efficacy and safety of ZYMFENTRA™, the first and only FDA-approved subcutaneous infliximab[1],[2]- Data from a post-hoc analysis of the LIBERTY-CD study showed that, despite affecting drug levels, anti-drug antibodies (ADAs) status appeared to have no significant impact on W54 clinical outcomes or discontinuation […]
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Celltrion USA announces two-year data for ZYMFENTRA™(infliximab-dyyb) to be presented at Digestive Disease Week (DDW) 2024 Conference
– Data presentations including the extended LIBERTY studies to highlight the long-term treatment goals of ZYMFENTRA™, the first and only FDA-approved subcutaneous infliximab- The data underscores Celltrion’s commitment to improving patient outcomes and advancing scientific understanding in the field of IBDJERSEY CITY, N.J., May 17, 2024 – Celltrion USA today announced it will present the two-year results […]
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Celltrion USA's adalimumab-aaty biosimilar to HUMIRA® now available at low wholesale acquisition cost
Adalimumab-aaty will be priced at an 85% discount to HUMIRA® (adalimumab)Branded and unbranded versions of Celltrion USA’s adalimumab biosimilar help provide more affordable options for patientsJERSEY CITY, N.J., May 9, 2024 /PRNewswire/ — Celltrion USA announced today that adalimumab-aaty, the company’s high-concentration (100 mg/mL) and citrate-free formulation biosimilar to HUMIRA ® (adalimumab), is now available at a low wholesale acquisition cost (WAC). Adalimumab-aaty will be […]
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ZYMFENTRA™(infliximab-dyyb), the first and only FDA-approved subcutaneous infliximab, now commercially available in the U.S.
ZYMFENTRA™ is the first FDA-approved subcutaneous infliximab for the treatment of moderately to severely active ulcerative colitis and moderately to severely active Crohn’s diseaseZYMFENTRA™ is commercially available across the U.S. on March 15, 2024JERSEY CITY, N.J., March 17, 2024 /PRNewswire/ — Celltrion USA announced today the availability of a ZYMFENTRA™ (infliximab-dyyb), a subcutaneous (SC) formulation of infliximab.[1] ZYMFENTRA is the first and only subcutaneous […]
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Celltrion completes submission of Biologics License Application (BLA) to U.S. FDA for CT-P39, an interchangeable biosimilar candidate of XOLAIR® (omalizumab)
The BLA for CT-P39 was based on totality of evidence including results from Phase III data demonstrating comparable efficacy and safety profile with the reference product XOLAIR® (omalizumab) in patients with chronic spontaneous urticaria JERSEY CITY, N.J., March 10, 2024 /PRNewswire/ — Celltrion today announced that the company has submitted a Biologics License Application (BLA) for CT-P39, an interchangeable […]
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