Fresenius Kabi’s biosimilar Tyenne® (tocilizumab-aazg) becomes the first IV and subcutaneous tocilizumab biosimilar approved by the FDA
07 Mar 2024
Drug ApprovalPatent InfringementLicense out/inPatent Expiration
Fresenius Kabi announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved Tyenne® (tocilizumab-aazg), its tocilizumab biosimilar referencing Actemra®* (tocilizumab). Tyenne® becomes the first tocilizumab biosimilar with both IV and subcutaneous formulations approved by the FDA. In accordance with its patent settlement agreement with Genentech, Fresenius Kabi has a license to market its tocilizumab product in the U.S. commencing on the license dates, which are confidential.
Tyenne® is Fresenius Kabi’s third approved U.S. biosimilar and another landmark in the company’s growth strategy towards #FutureFresenius. Recent launches were Tyenne® to treat inflammatory and autoimmune diseases in the EU as well as Idacio® and Stimufend®, expanding treatment options for autoimmune diseases and cancer in the U.S.
* Actemra® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.
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