Korea Biomedical Review reported on 31 March 2025 that Celltrion has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) regarding its autoinjector formulation of Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab). The injector formulation will be supplied in 75mg and 150mg doses.
Celltrion’s omalizumab biosimilar was approved (in pre-filled syringe) in the US in March 2025, Canada in December 2024, Australia in November 2024, the UK in July 2024, Korea in June 2024 and Europe in May 2024.