WESTON (dpa-AFX) - 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.



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