CHMP positive recommendation for Tofidence (tocilizumab biosimilar)

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: Benpali (etanercept), Imraldi(adalimumab) and Flixabi (infliximab), offering an extension to the cost-effective treatment options with an additional mechanism of action.

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 III 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.

Biogen and Bio-Thera entered into a commercialization and licensing agreement for Tofidence (BAT1806/BIIB800) in April 2021. Under the agreement, Tofidence, developed by Bio-Thera, is to be commercialized by Biogen in the European Union. Under the agreement, Biogen has exclusive regulatory, manufacturing, and commercial rights to Tofidence in all countries excluding China (including Hong Kong, Macau and Taiwan).