On 15 January 2025, Gedeon Richter and Mochida Pharmaceutical Co. announced positive topline results from Phase 1 and Phase 3 clinical studies for RGB-19, biosimilar to Roche’s Actemra® (tocilizumab). The Phase 1 study evaluated the pharmacokinetic equivalence between RGB-19 and its reference biologic in healthy adults. The Phase 3 study was a multicentre efficacy and safety comparability study in patients with rheumatoid arthritis. Both studies met their primary endpoints.
RGB-19 is being co-developed by Mochida and Gedeon Richter. Mochida expects to file marketing authorisation applications for RGB-19 in Japan, while Richter expects to do so in major global markets outside Japan.
The first tocilizumab biosimilar launched in Europe was Fresenius Kabi’s Tyenne®, in both IV and SC forms, in November 2023. This was followed by the EU approval of Biogen’s IV tocilizumab, Tofidence™, in June 2024. Fresenius launched the IV formulation of Tyenne® in the US in April 2024 and the SC formulation in July 2024.