FDA Approves Biogen's TOFIDENCE, A Biosimilar Referencing ACTEMRA
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The FDA has approved Biogen's TOFIDENCE (BIIB800), a biosimilar referencing ACTEMRA. This makes TOFIDENCE the first tocilizumab biosimilar to gain FDA approval in the United States. The approval is based on a robust analytical, non-clinical, and clinical data package comparing TOFIDENCE to the reference product ACTEMRA.
September 29, 2023 | 8:08 pm
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POSITIVE IMPACT
Biogen's TOFIDENCE has been approved by the FDA, making it the first tocilizumab biosimilar to gain such approval in the US. This could potentially increase Biogen's market share in the biosimilar industry.
FDA approval of a new drug typically leads to increased sales and market share for the company that produces it. In this case, Biogen's TOFIDENCE is the first of its kind to be approved in the US, which could give Biogen a significant advantage in the biosimilar market.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100