The European Commission has granted marketing authorization for Gedeon Richter Ltd.’s Tuyory, a medicinal product intended for the treatment of chronic inflammatory diseases. This decision elevates the company’s biotechnology division to a new level, expanding the range of therapies available in Europe.
Under the decision, the medicine will be available not only in the European Union but also in Iceland, Liechtenstein, and Norway.
Tuyory is a biosimilar containing tocilizumab (an antibody that blocks interleukin-6 receptors to treat severe inflammation) and an alternative to the reference medicinal product RoActemra.
The purpose of such medicines is to provide similar efficacy and safety to the original biological therapies, but at a lower price, making them accessible to a larger patient population.
The product was developed by Budapest-based Richter in cooperation with the Japanese company Mochida Pharmaceutical.
The basis for approval was the positive opinion of the European Medicines Agency (EMA) expert committee, the Committee for Medicinal Products for Human Use (CHMP), published on February 27, 2026. This opinion is a crucial step in the EU approval process for any new medicinal product.
According to the company, this decision not only represents the launch of a new product, but also an important strategic advancement. Erik Bogsch, head of Richter’s biotechnology division, stated:
The approval of Tuyory is an important milestone that brings the company closer to its goal of enabling people with chronic inflammatory diseases to access high-quality biological products.”
The rise of biosimilars has been one of the most important trends in the pharmaceutical industry in recent years. These therapies are particularly significant for diseases such as rheumatoid arthritis or other autoimmune conditions, where the cost of long-term treatment places a considerable burden on both healthcare systems and patients.
Via gedeonrichter.com, Featured image: Hungary Today
