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Celltrion Submits its Xolair® (omalizumab) Biosimilar MAA in Canada

Dec 27, 2023

The Korea Biomedical Review reported that Celltrion has submitted its marketing authorisation application for CT-P39, its biosimilar to Xolair® (omalizumab) to Health Canada.  The application includes all Xolair® indications, including allergic asthma, chronic rhinosinusitis and chronic urticaria.

Celltrion applied for European marketing authorisation for CT-P39 in April 2023.