Biogen gets FDA approval for biotech treatment similar to Roche’s Actemra

Biogen Inc.
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said late Friday the Food and Drug Administration approved its biosimilar version of Roche
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‘s arthritis treatment Actemra. Biogen said its treatment Tofidence, or tocilizumab-bavi, is the first FDA-approved biosimilar to tocilizumab, which Roche brands as Actemra. Biogen’s approval covers marketing for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis, the company said. Biosimilars are to branded biologics the way generic drugs are to branded drugs except the FDA regulates the two classes in different ways.