Posted by Michael Wonder on 01 Oct 2023
FDA approves Biogen’s Tofidence (tocilizumab-bavi), a biosimilar referencing Actemra
29 September 2023 - Tofidence (BIIB800) becomes the first tocilizumab biosimilar to gain FDA approval in the US.
Biogen announced that the US FDA has approved Tofidence (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing Actemra. The Tofidence intravenous formulation is approved for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.
