On September 29, the U.S. Food and Drug Administration granted approval for Tofidence®, a biosimilar produced by Biogen, for Genentech’s Actemra®. As reported, this marks a significant step for Biogen in the biosimilar sector.
Actemra®, originally developed and marketed by Genentech, is a widely used medication designed to treat a variety of severe medical conditions. Its applications include the treatment of COVID-19, rheumatoid arthritis, giant cell arteritis, scleroderma, as well as polyarticular or systemic juvenile idiopathic arthritis, and severe cytokine release syndrome.
With this approval, Biogen’s Tofidence® has become a directly approved alternate to Genentech’s Actemra®. As a biosimilar, Tofidence® is designed to have similar therapeutic effects as its reference product Actemra®.
It’s notable that this isn’t Biogen’s first foray into the biosimilar landscape. The company has a record of multiple successful approvals of biosimilars, contributing to a growing market trend that provides more alternatives for healthcare professionals and patients.
The approval of Tofidence® is the latest development as biosimilars continue to gain traction in the global pharmaceutical market. The FDA’s decision sets the stage for an interesting period of product competition that will likely have implications for patent landscapes, market shares, and could potentially contribute to a reduction in healthcare costs.