On October 5, 2026, Celltrion USA announced that OMLYCLO® (omalizumab-igec) is commercially available in the United States. OMLYCLO® is the first and only FDA-approved interchangeable biosimilar to Genentech and Novartis’s XOLAIR® (omalizumab).
As we previously reported, the FDA approved the anti-IgE antibody in March 2025 for all four XOLAIR® indications: moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), Immunoglobulin E (IgE)-mediated food allergy, and chronic spontaneous urticaria (CSU). OMLYCLO® is now available in the U.S. in 75 mg, 150 mg, and 300mg doses in a prefilled syringe for subcutaneous injection. Celltrion first launched OMLYCLO® in Europe in 2025.
In its announcement, Dr. Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion USA said, “The introduction of the first interchangeable omalizumab biosimilar provides a new opportunity to improve affordability and expand access, enabling health plans to offer more patients a proven treatment option.”