Gedeon Richter announces today that the European Commission (EC) granted marketing authorization for Tuyory®, its biosimilar to RoActemra® tocilizumab. The EC decision followed a positive opinion received from the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”), as reported on 27 February 2026, and is applicable for the EU, Iceland, Liechtenstein and Norway.

Tuyory® has been developed jointly by Richter and Mochida Pharmaceutical Co., Ltd.

“The recent approval of our biosimilar tocilizumab, Tuyory® is a major milestone for our biotechnology platform and for our mission to improve access to high‑quality biologic therapies for patients battling with chronic inflammatory conditions. This approval demonstrates our continued strength in successfully developing biosimilars and supports our rheumatology portfolio, enabling us to bring an affordable and trusted, European-developed and manufactured treatment option to patients across Europe and beyond” - said Dr. Erik Bogsch, Head of the Biotechnology Business Unit at Richter.

About Tuyory®               

Tocilizumab, the active ingredient of Tuyory® inhibits IL-6 signaling and is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis, cytokine release syndrome and COVID-19.

Tuyory® can be administered intravenously and subcutaneously, with dosing regimens and presentations identical to those of the reference medicine.

About Richter

Richter aspires to be a global innovator in some key scientific fields, while dedicated to making medicines more accessible worldwide. Founded in 1901, headquartered in Hungary, with a market capitalization of EUR 4.8bn and sales of EUR 2.3bn in 2025, it operates Central Europe's largest R&D hub. Its research drives breakthroughs in Neuropsychiatry and Women's Healthcare, while Biotechnology and General Medicines strengthen its affordable treatment portfolio. Committed to sustainable growth, Richter invests in R&D, manufacturing excellence, and digitalization to advance medical innovation. Learn more at www.gedeonrichter.com

 

 

For further information:

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Media:               Zsuzsa Beke                                                                           +36 20 916 4507