Celltrion Launches OMLYCLO, First Interchangeable Omalizumab Biosimilar In U.S.

India, Oct. 5 -- Celltrion USA said OMLYCLO (omalizumab-igec), the first and only FDA-approved interchangeable biosimilar to XOLAIR (omalizumab), is now commercially available in the U.S.

OMLYCLO is approved for all four indications of XOLAIR: moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, IgE-mediated food allergy and chronic spontaneous urticaria.

The product is available in 75 mg/0.5 mL, 150 mg/mL and 300 mg/2 mL single-dose prefilled syringes for subcutaneous injection.

OMLYCLO was approved by the FDA in March 2025 as an interchangeable biosimilar based on data demonstrating therapeutic equivalence to XOLAIR. It was also approved by the European Commission in May 2024.

Celltrion said the launch expan...