FDA Approves Biogen's Tofidence

(RTTNews) - Biogen Inc. (BIIB) announced that the U.S. Food and Drug Administration has approved Tofidence (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing Actemra.

The Tofidence intravenous formulation is approved for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.

Tofidence is the first tocilizumab biosimilar approved in the United States. Biosimilars are biologic products that have been demonstrated to have equivalent efficacy and comparable safety as the approved reference product, with the advantage that they may offer cost savings and promote expanded and sustainable access to therapies.

"The approval of TOFIDENCE in the U.S. marks another positive step toward helping more people with chronic autoimmune conditions gain access to leading therapies," said Ian Henshaw, Global Head of Biosimilars at Biogen. "With the increasing numbers of approved biosimilars, we expect increased savings and sustainability for healthcare systems and an increase in physician choice and patient access to biologics."