Tagged as: roActemra

Biogen Announces EMA Acceptance of Tocilizumab Biosimilar Application

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…

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Biogen and Bio-Thera Announce Positive Phase 3 Results On Tocilizumab Biosimilar

Biogen Inc. and Bio-Thera Solutions, Ltd. today announced positive Phase 3 results on BAT1806, a proposed biosimilar to ACTEMRA®/RoACTEMRA (tocilizumab). According to the Biogen press release, the study met its primary endpoints, demonstrating equivalent efficacy and comparable safety to the reference product in patients with moderate to severe rheumatoid arthritis…

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