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EMA Accepts Gedeon Richter’s Application for Biosimilar Tocilizumab

Mar 27, 2025

On 27 March 2025, Gedeon Richter announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application (MAA) for RGB-19, biosimilar to Roche’s RoActemra® (tocilizumab).  This follows Gedeon’s announcement of positive topline results from Phase 1 and Phase 3 clinical studies for RGB-19 in January 2025, both of which met their primary endpoints.

RGB-19 was co-developed by Mochida and Gedeon Richter.  Mochida will file marketing authorisation applications for RGB-19 in Japan, while Richter will do so in major global markets outside Japan.

In February 2025, Celltrion’s Avtozma® became the third tocilizumab biosimilar approved in the EU, following Fresenius Kabi’s Tyenne®, in both IV and SC forms, in November 2023, and Biogen’s IV Tofidence™, in June 2024.