On 23 March 2026, Mochida Pharmaceutical and Ayumi Pharmaceutical announced that RGB-19, biosimilar to Roche’s RoActemra® (tocilizumab) was approved in Japan. The approval covers forms of the biosimilar for intravenous infusion, subcutaneous injection and in an autoinjector.
RGB-19 was co-developed by Mochida and Gedeon Richter, with Mochida filing marketing authorisation applications for RGB-19 in Japan, and Richter doing so in major global markets outside Japan. Under a collaboration agreement between Mochida and Ayumi in relation to commercialisation of RGB-19 in Japan, Mochida is responsible for supplying the product to Ayumi, which is in turn responsible for sales in the country.
RGB-19 received a positive CHMP opinion in Europe in February 2026 under the brand name Tuyory®. This followed Gedeon Richter’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.
The first tocilizumab biosimilar approved in Japan was Celltrion’s Avtozma®/CT-P47, in September 2025. Avtozma® has also been granted marketing authorisation in a number of other regions, including the US (January 2025) and EU (February 2025), following approval of Biogen/Bio-Thera’s Tofidence®/BAT1806 (US: September 2023, EU: June 2024) and Fresenius Kabi’s Tyenne® (US: March 2024, EU: November 2023). Avtozma® was the first tocilizumab biosimilar approved in Australia (May 2025), and New Zealand (December 2025).