FDA Clears Actemra Biosimilar Tofidence

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Bio-Thera Solutions, Ltd revealed that it has received FDA approval for Tofidence (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing Actemra. The treatment is approved for the treatment of patients with moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.

Bio-Thera and Biogen entered a partnership to develop Tofidence in April 2021.

"The approval of TOFIDENCE is a landmark achievement for Bio-Thera as it marks Bio-Thera's first FDA approval for a product in the United States" said Shengfeng Li, CEO, Bio-Thera. "Bio-Thera is committed to developing biosimilars for patients around the globe and this approval demonstrates that commitment."

Reference: FDA Approves TOFIDENCE™ (tocilizumab-bavi) a Biosimilar of ACTEMRA® developed by Bio-Thera Solutions. PR Newswire. October 8, 2023. Accessed October 9, 2023. https://www.prnewswire.com/news-releases/fda-approves-tofidence-tocilizumab-bavi-a-biosimilar-of-actemra-developed-by-bio-thera-solutions-301950199.html