First Biosimilar Approval Alert: Roche On Notice As FDA Approves First Tocilizumab Biosimilar with Biogen’s Tofidence®

Biogen announced that the FDA has approved Tofidence®, its biosimilar to Roche’s Actemra®/ RoActemra® (tocilizumab) for treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.  Tofidence® is the first FDA approved tocilizumab biosimilar.

On 19 September 2023, the European Commission approved Fresenius Kabi’s Tyenne®, also a biosimilar to Roche’s Actemra® / RoActemra®, which is the first EU approved biosimilar to tocilizumab.