The latest on building what’s next.

The Biologics License Application for CT-P47 was based on Phase III data comparing CT-P47 to the reference product ACTEMRA® (tocilizumab) JERSEY CITY, N.J., Jan. 28, 2024 /PRNewswire/ — Celltrion USA today announced the submission of Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for CT-P47, a biosimilar candidate of the reference product ACTEMRA® (tocilizumab)[1].The BLA […]

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 […]

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 […]

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 […]

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 […]

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, […]