Celltrion Leads Xolair Biosimilar Race With US FDA Application

The Application Was Based On The Totality of Evidence From Several Trials

This marks Celltrion’s second regulatory submission for an omalizumab biosimilar as the US formulation patent protecting originator Xolair is set to expire late next year.

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Celltrion continues to establish its frontrunner position in the omalizumab biosimilar race as the firm submits a biologic license application to the US Food and Drug Administration for its CT-P39, an interchangeable biosimilar candidate to Genentech/Novartis’ Xolair.

The application includes all indications that Xolair is approved for such as asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous

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