Celltrion applies for EMA marketing authorisation of its biosimilar to Genentech/Novartis’ Xolair® (omalizumab)

Korea BioMed reported that Celltrion has submitted its application in EMA for CT-P39 (omalizumab), a biosimilar to Genentech/Novartis’ Xolair®.  The reference product Xolair® is approved in Europe for the treatment of asthma, chronic spontaneous urticaria and severe chronic rhinosinusitis with nasal polyps, and in other markets.  On 10 April 2023, Celltrion announced its phase III safety and efficacy results for CT-P39.