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.