FDA accepts Biogen's BLA for Actemra biosimilar BIIB800

The US Food and Drug Administration (FDA) has accepted for review the abbreviated Biologics License Application (BLA) submitted by biotech major Biogen (Nasdaq: BIIB) for BIIB800, a biosimilar candidate referencing Roche’s (ROG: SIX) Actemra, 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, systemic juvenile idiopathic arthritis, sclerosis-associated interstitial lung disease.

In September 2022, the Marketing Authorization Application (MAA) for BIIB800 was accepted for review by the European Medicines Agency (EMA).