Biogen : FDA Accepts BLA For BIIB800, Biosimilar Candidate Referencing ACTEMRA

(RTTNews) - The U.S. Food and Drug Administration has accepted for review the abbreviated Biologics License Application (aBLA) for BIIB800, a biosimilar candidate referencing ACTEMRA (tocilizumab), an anti-interleukin-6 receptor monoclonal antibody, Biogen Inc. (BIIB) said in a statement on Friday.

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.

Biosimilars are biological products that have been demonstrated to be similar in efficacy and safety to the originator's reference product, with the advantage that they offer healthcare savings and promote sustainable access to therapies.

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