Celltrion seeks approval for Xolair biosimilar in EU

Korea Biomedical Review

25 April 2023 - Celltrion said it has completed a marketing authorization application for CT-P39, a biosimilar referencing Xolair (omalizumab) to the EMA.

Xolair, the original drug, is an antibody biologic developed by Genentech and Novartis for the treatment of allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic idiopathic urticaria.

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Michael Wonder

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Michael Wonder

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Medicine , Europe , Biosimilar , Dossier