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CHMP adopts positive opinion for three biosimilars

Jul 21, 2023

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for three biosimilars:

  • Fresenius Kabi’s Tyenne® (tocilizumab), biosimilar to Roche’s Actemra® / RoActemra®. Tyenne® is 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.
  • Sandoz’s Tyruko® (natalizumab), biosimilar to Biogen’s Tysabri®.  Tyruko® is intended to treat active relapsing remitting multiple sclerosis.
  • BGP Pharma’s Yesafili® (aflibercept), a biosimilar to Regeneron’s Eylea®. It is intended to treat age-related macular degeneration

To obtain approval in Europe, the European Commission needs to approve the above positive recommendations from the CHMP.

During this same July 2023 CHMP meeting, the CHMP also issued a positive opinion for BMS’s Opdivo® (nivolumab) to treat completely resected stage IIB or IIC melanoma and Merck’s Keytruda® (pembrolizumab) to treat HER2-Positive Advanced Gastric or Gastroesophageal Junction.