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FDA Approves Bio-Thera’s Biosimilar of ACTEMRA

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

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...

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