Biogen Inc. (“Biogen”) recently announced that the European Medicines Agency (EMA) has accepted the marketing authorization application for BIIB800 (BAT1806), a biosimilar candidate referencing Roche’s ACTEMRA (tocilizumab).  ACTEMRA, an anti-interleukin-6 receptor monoclonal antibody, is approved in Europe as an intravenous formulation for severe, active and progressive rheumatoid arthritis, juvenile idiopathic polyarthritis, active system juvenile idiopathic arthritis, and cytokine release syndrome.

This marketing authorization includes positive Phase 3 data from a comparative clinical trial demonstrating that BIIB800 has equivalent efficacy and a comparable pharmacokinetics, safety and immunogenicity profile to ACTEMRA in patients with moderate to severe rheumatoid arthritis inadequately controlled with methotrexate therapy.  “If approved, BIIB800 will be a valuable treatment option for people with chronic immune mediated inflammatory diseases,” said Ian Henshaw, Head of Global Biosimilars at Biogen.

As we previously reported, Biogen and Bio-Thera Solutions, Ltd. announced a commercialization and license agreement to develop, manufacture, and commercialize BIIB800 (BAT1806) in April 2021, announced positive phase 3 results in June 2021, and received similar marketing authorization acceptance from China’s National Medical Products Administration in November 2021.

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