Biogen Receives Positive CHMP Opinion for TOFIDENCE (tocilizumab), a Biosimilar Referencing ROACTEMRA

• CHMP positive opinion is based on a robust analytical, non-clinical and clinical data package comparing TOFIDENCE to the reference product ROACTEMRA

CAMBRIDGE, Mass., April 25, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for TOFIDENCE (tocilizumab), a biosimilar monoclonal antibody referencing ROACTEMRA¹. The intravenous formulation of TOFIDENCE has been recommended for approval for the treatment of moderate to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19.

The CHMP’s positive opinion will now be referred to the European Commission (EC), which will decide whether to grant marketing authorization for TOFIDENCE. If a marketing authorization is granted by the EC, TOFIDENCE will be an addition to the existing biosimilars portfolio of three widely prescribed anti-TNF biosimilars commercialized by Biogen in Europe: BENEPALI (etanercept), IMRALDI (adalimumab) and FLIXABI (infliximab), offering an extension to the cost-effective treatment options with an additional mechanism of action.

“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,” said Ian Henshaw, Global Head of Biosimilars at Biogen. “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.”

This positive CHMP opinion on TOFIDENCE was based on the totality of evidence comprising a comprehensive analytical, non-clinical and clinical data package. Extensive analytical characterization of the structural, physicochemical, and biological properties of TOFIDENCE was conducted and supports equivalence with the reference biologic product. Additionally, a randomized double-blind, single-dose, three-arm, parallel group Phase 1 study compared the pharmacokinetics, safety and immunogenicity of TOFIDENCE with both the EU and US reference tocilizumab in healthy volunteers, while a randomized, double-blind, multi-dose, three-arm, parallel group Phase 3 study compared TOFIDENCE with tocilizumab to establish equivalent efficacy and comparable pharmacokinetic, safety and immunogenicity profiles, in subjects with rheumatoid arthritis inadequately controlled by methotrexate. The totality of evidence demonstrated TOFIDENCE is a biosimilar of the reference biologic.