FDA Accepts Biogen Biologics License Application for BIIB800, Referencing ACTEMRA

  Biogen Inc. (Nasdaq: BIIB) – announced that the U.S. Food and Drug Administration (FDA) has accepted for review the abbreviated Biologics License Application (aBLA) for BIIB800, a biosimilar candidate referencing ACTEMRA®1 (tocilizumab), an anti-interleukin-6 receptor monoclonal antibody.

ACTEMRA® is indicated for several indications, including moderate to severe rheumatoid arthritis in adults as well as juvenile idiopathic polyarthritis and systemic juvenile idiopathic arthritis.

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