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Approval Alert: Biogen’s Tocilizumab Biosimilar EU Approved

Jun 24, 2024

On 24 June 2024, Biogen announced its IV tocilizumab, TOFIDENCE™, biosimilar to Roche’s ROACTEMRA®, has been approved by EC.  Tofidence is authorised by the EC for treating moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19.   

This is the second tocilizumab biosimilar approved in the EU following the approval of Fresenius Kabi’s tocilizumab biosimilar, Tyenne® for the treatment of rheumatoid arthritis in September 2023. 

This approval follows the positive opinion from EMA’s Committee for Medicinal Products for Human Use (CHMP) for Tofidence in April 2024, and the FDA approval of Biogen’s Tofidence in September 2023.