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FDA Approves Celltrion’s Biosimilar to XOLAIR

The approval of OMLYCLO was based on comprehensive clinical evidence, including results from a global Phase III clinical trial.

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By: Charlie Sternberg

Associate Editor

The U.S. Food and Drug Administration (FDA) has approved Celltrion’s OMLYCLO (omalizumab-igec) as the first and only biosimilar designated as interchangeable with XOLAIR (omalizumab) for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), Immunoglobulin E (IgE)-mediated food allergy, and chronic spontaneous urticaria (CSU). “We are proud to achieve the approval of the first biosimilar to omalizumab in the U.S., which will help broade...

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