Biogen's Tofidence Bags US FDA Approval To Treat Rheumatoid Arthritis

Tofidence (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing Actemra, has been authorized by the US Food and Drug Administration (FDA). The intravenous formulation of Tofidence has been authorized 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. Spending on therapies for autoimmune diseases has consistently increased by 10%–25% each year over the past decade. Since biosimilar entry in the US, medicines with biosimilar competition have experienced greater patient adoption equaling more than 150 million days of patient therapy, as per pharmabiz.

“The approval of Tofidence in the US 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.” Tofidence was commercialized and licensed by Biogen and Bio-Thera in April 2021. Tofidence, developed by Bio-Thera, will be sold in the United States by Biogen. Biogen owns exclusive regulatory, manufacturing, and commercial rights to Tofidence in all countries except China (including Hong Kong, Macau, and Taiwan) under the agreement. Tofidence's possible launch timeframe in the United States is presently being evaluated by Biogen.