Biogen announces FDA accepted for review the aBLA for BIIB800

Biogen 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, an anti-interleukin-6 receptor monoclonal antibody. "The FDA filing is supported by Phase 3 data from a comparative clinical trial demonstrating equivalent efficacy and a comparable safety and immunogenicity profile to the reference product," said Ian Henshaw, Head of Global Biosimilars at Biogen. "We look forward to working with regulators to bring this potential treatment option for people with immune mediated inflammatory diseases." In September 2022, the Marketing Authorization Application for BIIB800 was accepted for review by the European Medicines Agency.