FDA Approves Biogen’s TOFIDENCE™ (tocilizumab-bavi), a Biosimilar Referencing ACTEMRA

 

• TOFIDENCE (BIIB800) becomes the first tocilizumab biosimilar to gain FDA approval in the United States
  
• FDA approval is based on a robust analytical, non-clinical and clinical data package comparing TOFIDENCE to the reference product ACTEMRA

https://www.globenewswire.com/news-release/2023/09/29/2752273/0/en/FDA-Approves-Biogen-s-TOFIDENCE-tocilizumab-bavi-a-Biosimilar-Referencing-ACTEMRA.html