Bio-Thera Solutions obtains FDA OK for Actemra biosimilar

Bio-Thera Solutions’ partner Biogen recently received approval from the Food and Drug Administration for Tofidence (tocilizumab-bavi) intravenous formulation, a biosimilar to Genentech's 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 Bio-Thera's first FDA approved product in the United States, and the first biosimilar developed and manufactured by a Chinese pharmaceutical company approved in the United States.

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"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 at Bio-Thera. "Bio-Thera is committed to developing biosimilars for patients around the globe and this approval demonstrates that commitment."

Biogen and Bio-Thera entered into a partnership agreement for Tofidence in April 2021. Developed by Bio-Thera, Tofidence will be commercialized by Biogen in all countries excluding China (including Hong Kong, Macau and Taiwan).

[Read more: Challenges continue, but generics companies see a bright future with biosimilars]