European Acceptance for Richter's Drug, Tocilizumab

The Hungarian pharmaceutical company Gedeon Richter Plc. has announced on the website of the Budapest Stock Exchange that the European Medicines Agency (EMA) has accepted Richter’s marketing authorization application (MAA) for its proposed biosimilar to RoActemra tocilizumab.

Tocilizumab, the first biologic to inhibit IL-6 signaling, is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis, cytokine release syndrome and COVID-19.

Richter submitted a comprehensive analytical and clinical data package, which comprises data from a Phase I pharmacokinetic/pharmacodynamic (PK/PD) similarity study in healthy male volunteers and a multicenter efficacy and safety comparability Phase III study in patients with rheumatoid arthritis. According to the data package, Richter’s tocilizumab biosimilar matches the reference products in relation to PK, PD, efficacy, safety, and immunogenicity in the respective populations used in the studies. The data also contribute to the demonstration of similarity, which forms the basis for the biosimilar’s use in all indications of the originator’s product.

RGB-19 has been developed jointly by Richter and Mochida Pharmaceutical Co., Ltd. The Head of Richter's Biotechnology Business Unit, Dr. Erik Bogsch stressed in the statement that “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.”