(RTTNews) - Biogen Inc. (BIIB) announced Monday that the European Commission (EC) has granted approval for TOFIDENCETM, 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 company said 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.
The EC approval of TOFIDENCE is 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 comparability 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
A randomized, double-blind, multi-dose, three-arm, parallel group Phase 3 study also compared TOFIDENCE with tocilizumab to establish equivalent efficacy and comparable pharmacokinetic, safety and immunogenicity profiles.
The company said 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 in April 2021. Under the agreement, Biogen has exclusive regulatory, manufacturing, and commercial rights to TOFIDENCE in all countries excluding China, including Hong Kong, Macau and Taiwan.
