Celltrion launches FDA-approved interchangeable biosimilar OMLYCLO (omalizumab-igec) to XOLAIR

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OMLYCLO® (omalizumab-igec), the first and only FDA-approved interchangeable biosimilar to XOLAIR®, now commercially available in the U.S. OMLYCLO® (omalizumab-igec), the first and only FDA-approved interchangeable biosimilar to XOLAIR®, now commercially available in the U.S. News provided by Celltrion Oct 05, 2026, 08:45 ET Share this article Share to X Share this article Share to X OMLYCLO ® (omalizumab-igec) is the first and only FDA-approved omalizumab biosimilar approved for all four indications of XOLAIR ® (omalizumab) and designated as interchangeable with XOLAIR; OMLYCLO ® will be available in 75 mg/0.5 mL, 150 mg/mL and 300mg/2mL in a single-dose prefilled syringe for subcutaneous injection in the U.S. The availability of the first omalizumab biosimilar introduces an additional treatment option for eligible patients with allergic and inflammatory conditions JERSEY CITY, N.J. , Oct. 5, 2026 /PRNewswire/ -- Celltrion USA, Inc. today announced the availability of OMLYCLO ® (omalizumab-igec), the first and only U.S. Food and Drug Administration (FDA) approved interchangeable biosimilar to XOLAIR ® (omalizumab). OMLYCLO ® is now available in 75 mg/0.5 mL, 150 mg/mL and 300mg/2mL in a single-dose prefilled syringe for subcutaneous injection. OMLYCLO ® is approved 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). 1 As

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