Biogen announced that the European Commission has granted approval for TOFIDENCE, a biosimilar monoclonal antibody referencing ROACTEMRA. The intravenous formulation of TOFIDENCE has been granted marketing authorization by the EC for the treatment of moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19. “The approval of TOFIDENCE offers European patients with several inflammatory and immune-mediated inflammatory diseases access to an additional affordable biologic treatment option with comparable safety and efficacy to the approved reference product. By adding TOFIDENCE to our growing biosimilars portfolio, we can provide greater choice to physicians and patients whilst offering the potential for significant cost-savings across healthcare systems in Europe,” said Ian Henshaw, Global Head of Biosimilars at Biogen.
Elevate Your Investing Strategy:
- Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on BIIB:
- TOFIDENCE™ (tocilizumab), a Biosimilar Referencing ROACTEMRA®, Approved in the European Union
- Eli Lilly Stock (LLY) Gained on FDA Panel Approval
- FDA Accepts Eisai’s Filing of LEQEMBI® (lecanemab-irmb) Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease
- Eisai, Biogen say FDA accepted sBLA for monthly LEQEMBI IV maintenance dosing
- Biogen and Delta Flight Products to Collaborate with Advocates and Patients to Inform the Future of Accessible Air Travel