News Archive
Fresenius Kabi and Formycon Receive U.S. FDA Approval for Biosimilar Otulfi(TM)* (ustekinumab-aauz)
Fresenius Kabi announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved OtulfiTM (ustekinumab-aauz), its ustekinumab biosimilar referencing Stelara® ** (ustekinumab). OtulfiTM is approved for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis.
Fresenius Continues its Biopharma Momentum with Launch of Subcutaneous Formulation of Tyenne® (tocilizumab-aazg) in the United States
Fresenius Kabi announced today the immediate availability in the U.S. of its biosimilar Tyenne® (tocilizumab-aazg), in a subcutaneous formulation, which will increase access to affordable and cost-effective treatment options for use in the treatment in chronic autoimmune diseases.
Fresenius Accelerates Momentum in its (Bio)Pharma Business and Launches Tyenne®, its Third Approved Biosimilar in the U.S.
Tyenne® is the first tocilizumab biosimilar by Fresenius Kabi with an intravenous and subcutaneous formulation approved by the FDA. The tocilizumab biosimilar provides increased access and an affordable, high-quality, and safe treatment option for U.S. patients.
Fresenius Kabi’s Biosimilar Tyenne® (tocilizumab-aazg) becomes the first IV and Subcutaneous tocilizumab biosimilar approved by the FDA
Tyenne® provides a comprehensive, accessible, and high-quality treatment option for U.S. patients treated with tocilizumab.
IDACIO® (adalimumab-aacf) Now Available in the United States
Fresenius Kabi announced today the immediate availability in the U.S. of its citrate-free adalimumab biosimilar IDACIO® (adalimumab-aacf) for use in the treatment of chronic autoimmune diseases for all eligible indications of the reference product, Humira® (adalimumab).
CMS grants Fresenius Kabi permanent, product-specific Q-Code for Stimufend® (pegfilgrastim-fpgk)
The approval of the adalimumab biosimilar, adalimumab-aacf, signals the beginning of Fresenius Kabi’s long-term dedication to biosimilars.
Stimufend® (pegfilgrastim-fpgk) Now Available in the United States
Fresenius Kabi announced today the immediate availability in the U.S. of Stimufend®(pegfilgrastim-fpgk), the company’s biosimilar to Neulasta® (pegfilgrastim), for use in patients at risk for febrile neutropenia
Biosimilar Adalimumab-aacf Gains FDA Approval, Marks Growing Interest in Biosimilar Development
The approval of the adalimumab biosimilar, adalimumab-aacf, signals the beginning of Fresenius Kabi’s long-term dedication to biosimilars.
