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FDA Approves Bio-Thera’s Biosimilar of ACTEMRA

TOFIDENCE becomes the first biosimilar to Actemra approved by the FDA.

By: Anthony Vecchione

The FDA approved Bio-Thera Solutions, Ltd’s TOFIDENCE (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing Genentech’s ACTEMRA. The TOFIDENCE IV formulation is approved for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.

TOFIDENCE (BAT1806 / BIIB800) is Bio-Thera’s first FDA approved product in the U.S., and the first biosimilar developed and manufactured by a Chinese pharmaceutical company approved in the U.S.

Tocilizumab-bavi is a monoclonal antibody that binds to interlukin-6 receptors and is used to treat various inflammatory autoimmune conditions, including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.

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).

The FDA approval of TOFIDENCE was based on a comprehensive analytical, non-clinical and clinical data package submitted by Biogen to the FDA in Sept 2022.

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