FDA Accepts Biogen’s aBLA for Tocilizumab

On December 9, 2022, Biogen announced that the FDA has accepted for review an aBLA for BIIB800, Biogen’s tocilizumab biosimilar candidate.  BIIB800 references Genetech’s ACTEMRA product, which is an anti-interleukin-6 receptor monoclonal antibody indicated for moderate to severe rheumatoid arthritis in adults as well as juvenile idiopathic polyarthritis and systemic juvenile idiopathic arthritis.  The FDA’s acceptance follows the EMA’s acceptance of the marketing authorization application for BIIB800 earlier this year.

Biogen’s aBLA is the second BLA to be accepted by FDA for a tocilizumab biosimilar.  As we previously reported, the FDA accepted for review Fresenius Kabi’s tocilizumab BLA in August 2022.