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Gedeon Richter’s Tocilizumab Biosimilar EU-Approved

Apr 29, 2026

On 29 April 2026, Gedeon Richter announced that the European Commission has granted marketing authorisation for Tuyory ®, biosimilar to Roche’s RoActemra® (tocilizumab).  This follows a positive opinion for Tuyory® in February 2026 from the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP).

Tuyory® is approved in IV and SC formulations for the treatment of rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA), giant cell arthritis (GCA), cytokine release syndrome (CRS) and COVID-19.

Tuyory® was jointly developed by Gedeon Richter and Mochida Pharmaceutical, with Mochida being responsible for regulatory filings in Japan and Richter filing marketing authorisation applications in other countries.

There are 3 other tocilizumab biosimilars approved in Europe: Fresenius Kabi’s Tyenne® in both IV and SC forms (November 2023), STADA’s Tocilizumab STADA™ (previously Biogen’s Tofidence®) (June 2024) and Celltrion’s Avtozma® (February 2025).