FDA Clears New Prefilled Syringe Of Celltrion's OMLYCLO, Interchangeable Biosimilar To XOLAIR

(RTTNews) - Celltrion Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a new presentation of OMLYCLO (omalizumab-igec)—the first and only biosimilar designated as interchangeable with XOLAIR (omalizumab). The newly approved format is a 300mg/2mL solution in a single-dose prefilled syringe for subcutaneous injection. In the United States, OMLYCLO will be marketed and distributed exclusively by Celltrion USA, Inc.

In March 2025, the FDA approved OMLYCLO in 75 mg/0.5 mL and 150 mg/mL solutions in a single-dose prefilled syringe for subcutaneous injection 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).

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