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Biosimilar Update: Fresenius’ Actemra Biosimilar Now Available in the US

Fresenius’ Tyenne (tocilizumab-aazg), a biosimilar of Actemra (tocilizumab), is now available for use in the US.

Tyenne is the first tocilizumab biosimilar with an intravenous and subcutaneous formulation approved by the FDA. The biosimilar received FDA approval on March 5, 2024. Tyenne is Fresenius’ third approved biosimilar available in the U.S. and the second within its immunology portfolio. The biologic medicine is indicated for the treatment of several autoimmune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.

In addition to its two available biosimilars, Idacio (adalimumab) and Stimufend (pegfilgrastim), Fresenius Kabi has a growing pipeline of autoimmune and oncology biosimilars with several molecules in late-stage development.