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Europe’s CHMP Positive Opinion on Biogen’s Tocilizumab Biosimilar

Apr 25, 2024

On 25 April 2024, Biogen announced that its Tofidence™ (tocilizumab), biosimilar to Roche’s RoActemra®, received a positive opinion from EMA’s Committee for Medicinal Products for Human Use (CHMP).  The recommendation relates to the IV formulation of tocilizumab for the treatment of moderate to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19.  The Biogen application was accepted by EMA 19 months earlier in September 2022.

The product, previously known as BAT1806, was developed by Bio-Thera, and Biogen acquired exclusive rights in all countries other than China in a deal announced in April 2021.

This follows the FDA approval of Biogen’s Tofidence™ on 30 September 2023, and the US patent settlement between Roche, Genentech, Chugai and Biogen in October 2023.