Three biosimilars recommended for approval by EMA's CHMP

At its July meeting, the European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended three new biosimilars and rejected one application, as well as recommending 10 novel drugs.

The committee adopted a positive opinion for Fresenius Kabi’s Tyenne (tocilizumab), a biosimilar version of Roche’s (ROG: SIX) Actemra/RoActemra, a medicine intended 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 for this active substance.

The biosimilar medicine Tyruko (natalizumab), from Sandoz, received a positive opinion as therapy for active relapsing remitting multiple sclerosis, a disease of the brain and spinal cord in which inflammation destroys the protective covering around nerves and the nerves themselves. It is a biosimilar version of Biogen’s (Nasdaq: BIIB) Tysabri.