Pharma Focus Europe

TOFIDENCE™, a Biosimilar of ROACTEMRA® (Tocilizumab), Receives Approval in the European Union

Tuesday, June 25, 2024

Biogen Inc. (Nasdaq: BIIB) has received approval from the European Commission (EC) for TOFIDENCE™, a biosimilar monoclonal antibody referencing ROACTEMRA®1. This intravenous formulation is now authorized for treating moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19.

Ian Henshaw, Global Head of Biosimilars at Biogen, highlighted the approval's significance for providing European patients with additional affordable biologic treatment options that match the safety and efficacy of the reference product. The approval was supported by a comprehensive evaluation including analytical, non-clinical, and clinical data. Key studies demonstrated TOFIDENCE's comparability with tocilizumab, confirming its status as a biosimilar.

Under an agreement with Bio-Thera since April 2021, Biogen holds exclusive rights for regulatory, manufacturing, and commercialization of TOFIDENCE in all countries except China (including Hong Kong, Macau, and Taiwan).

TOFIDENCE, an interleukin-6 receptor antagonist, is indicated for the treatment of moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19, offering an important therapeutic option across several inflammatory and immune-mediated diseases.

 

Source: globenewswire.com

magazine-slider-img
Thermo Fisher Scientific - mRNA ServicesWorld Orphan Drug Congress 2024World Vaccine Congress Europe 2024Advanced Therapies USA 2024
cytiva