Fresenius Kabi Announces FDA Approval of TYENNE, a Tocilizumab Biosimilar Referencing ACTEMRA

On March 7, Fresenius Kabi announced that the FDA has approved its tocilizumab biosimilar, TYENNE (tocilizumab-aazg) for inflammatory and immune diseases indications including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.  TYENNE is the second FDA approved biosimilar of ACTEMRA (following Biogen’s TOFIDENCE (tocilizumab-bavi) intravenous formulation) and the first tocilizumab biosimilar approved in both intravenous and subcutaneous formulations.

TYENNE will be available in the U.S. at a future date “[i]n accordance with [Fresenius Kabi’s] patent settlement agreement with Genentech” under which Fresenius Kabi has a license to market its tocilizumab products in the U.S. starting at confidential license dates.