On September 29, the U.S. Food and Drug Administration announced approval of Biogen's Tofidence® (tocilizumab-bavi) as a biosimilar to Genentech's Actemra®, a drug approved for treating COVID-19, rheumatoid arthritis, giant cell arteritis, scleroderma, polyarticular or systemic juvenile idiopathic arthritis, and severe cytokine release syndrome. Tofidence® is the first Actemra biosimilar, and was approved as an intravenous formulation for treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.
This approval brings to 44 the number of approved biosimilar products.
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