Tofidence becomes first Actemra biosimilar to gain US approval

The US Food and Drug Administration (FDA) has approved Tofidence (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing Actemra, to be marketed by biotech major Biogen (Nasdaq: BIIB).

Like Swiss pharma giant Roche’s (ROG SIX) branded 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.

Biogen notes that Tofidence is the first tocilizumab biosimilar approved in the USA. In Europe, the first tocilizumab biosimilar was granted marketing authorization on September 19 for Fresenius Kabi’s Tyenne. Also marketed under the trade name RoActemra, the drug generated first-half 2023 sales of 1,296 million Swiss francs ($1.42 billion) for Roche.