Biogen Announces FDA Approval of TOFIDENCE, a Tocilizumab Biosimilar Referencing ACTEMRA

On September 29, 2023, Biogen announced the FDA approval of TOFIDENCE (tocilizumab-bavi) intravenous formulation which is the first tocilizumab biosimilar approved by the FDA in the United States.  TOFIDENCE is approved for the treatment of moderately to severely active rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (PJIA), and systemic juvenile idiopathic arthritis (SJIA).  “The approval of TOFIDENCE in the U.S. marks another positive step toward helping more people with chronic autoimmune conditions gain access to leading therapies,” said Ian Henshaw, Global Head of Biosimilars at Biogen.  According to Biogen, it is “currently evaluating the potential launch timeline for TOFIDENCE in the U.S.”  As we previously reported, Genentech filed a BPCIA complaint against Biogen regarding tocilizumab on July 13, 2023 seeking a judgement of infringement and the answer is due on October 17, 2023