Posted by Michael Wonder on 10 Dec 2022
FDA accepts Biogen biologics license application for BIIB800, a biosimilar candidate referencing Actemra (tocilizumab)
9 December 2022 - Biogen announced that the US FDA has accepted for review the abbreviated biologics license application for BIIB800, a biosimilar candidate referencing Actemra (tocilizumab), 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.”
