CHMP Grants Favorable Opinion to Biogen’s TOFIDENCE™ (tocilizumab), a Biosimilar of ROACTEMRA

Biogen Inc. (Nasdaq: BIIB) has announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a favorable opinion for TOFIDENCE™ (tocilizumab), a biosimilar monoclonal antibody referencing ROACTEMRA®1. The intravenous formulation of TOFIDENCE has received a recommendation for approval for treating moderate to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19.

This positive opinion from the CHMP will now proceed to the European Commission (EC), which will make the decision on granting marketing authorization for TOFIDENCE. If marketing authorization is granted, TOFIDENCE will join Biogen’s existing biosimilars portfolio in Europe, which includes three widely prescribed anti-TNF biosimilars: BENEPALI (etanercept), IMRALDI (adalimumab), and FLIXABI (infliximab). This addition will provide further cost-effective treatment options with a different mechanism of action.

Ian Henshaw, Global Head of Biosimilars at Biogen, commented, “The positive CHMP recommendation for TOFIDENCE marks another positive step toward helping more people with inflammatory and immune-mediated conditions gain access to leading therapies.” He added, “Positive CHMP recommendation for TOFIDENCE is testament to our continuing efforts to develop and deliver high-quality and proven biologic medicines to more patients, healthcare providers, and healthcare systems in Europe.”

The CHMP’s decision was based on a comprehensive package of evidence, including analytical, non-clinical, and clinical data. Extensive analytical characterization demonstrated equivalence between TOFIDENCE and the reference biologic product. Clinical studies, including Phase 1 and Phase 3 trials, established the efficacy and safety of TOFIDENCE compared to tocilizumab in patients with rheumatoid arthritis inadequately controlled by methotrexate.

TOFIDENCE (BAT1806/BIIB800) is developed by Bio-Thera and commercialized by Biogen in the European Union under a commercialization and licensing agreement signed in April 2021. Biogen holds exclusive regulatory, manufacturing, and commercial rights to 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. It can be administered as monotherapy or in combination with other treatments depending on the condition and patient response.

In summary, the positive CHMP opinion for TOFIDENCE represents a significant advancement in providing effective and accessible treatment options for patients with various inflammatory and immune-mediated conditions in Europe.

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