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Gedeon Richter Plc. has submitted a marketing authorization application (MAA) to the European Medicines Agency for its proposed biosimilar to RoActemra® tocilizumab (RGB-19), the Budapest-based pharmaceutical company announced on Thursday.
In a statement, the company revealed that the European Medicines Agency (EMA) has accepted the application. Tocilizumab is the first biologic to inhibit 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.
Based on the analytical and clinical data package submitted, the tocilizumab developed by Richter shows a comparable result to the reference product in terms of efficacy, safety, and immunogenicity in the respective populations used in the studies.
RGB-19 has been developed jointly by Richter and Mochida Pharmaceutical Co., Ltd. of Japan.
“The submission of the tocilizumab biosimilar to the EMA is yet another milestone in building Richter’s affordable medicines portfolio.
This biosimilar – when approved – will provide access to a broad range of our patients in Europe to this important biological drug,”
the statement quoted Erik Bogsch, Head of the Biotechnology Business Unit.
Via Gedeon Richter Plc., Featured image: Hungary Today