March 27, 2025 I Gedeon Richter Plc. announces today that the European Medicines Agency has accepted Richter’s marketing authorization application (MAA) for its proposed biosimilar to RoActemra® tocilizumab – development code: RGB-19. 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 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” – said Dr. Erik Bogsch, Head of the Biotechnology Business Unit.
About Gedeon 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 4.7bn and sales of EUR 2.2bn in 2024, 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
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March 27, 2025 I Gedeon Richter Plc. announces today that the European Medicines Agency has accepted Richter’s marketing authorization application (MAA) for its proposed biosimilar to RoActemra® tocilizumab – development code: RGB-19. 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 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” – said Dr. Erik Bogsch, Head of the Biotechnology Business Unit.
About Gedeon 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 4.7bn and sales of EUR 2.2bn in 2024, 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
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