Fresenius Kabi announced that its Tyenne® (tocilizumab), biosimilar to Roche’s Actemra® / RoActemra® has been approved by the European Commission (EC) for the treatment of rheumatoid arthritis, active systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis, chimeric antigen receptor T cell-induced cytokine release syndrome, and COVID-19. Tyenne® is the first biosimilar to Actemra® / RoActemra® approved by the EC.
The CHMP issued a positive opinion recommending approval of Tyenne® on 21 July 2023.