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

Celltrion USA has officially launched OMLYCLO (omalizumab-igec), marking a significant milestone as it becomes the first and only FDA-approved interchangeable biosimilar to XOLAIR available in the United States.

OMLYCLO is approved for various indications, including moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, IgE-mediated food allergies, and chronic spontaneous urticaria. The product is offered in three different dosages: 75 mg/0.5 mL, 150 mg/mL, and 300 mg/2 mL, all in single-dose prefilled syringes for subcutaneous injection.

The FDA granted approval for OMLYCLO in March 2025 based on comprehensive data demonstrating its therapeutic equivalence to XOLAIR. Additionally, the European Commission approved the biosimilar in May 2024, further expanding its reach in the global market.

Celltrion aims to enhance treatment options for patients suffering from allergic and inflammatory conditions, thereby improving access to biologic therapies. The launch of OMLYCLO signifies Celltrion's commitment to expanding its biosimilar portfolio, which already includes treatments across various medical fields such as immunology, oncology, and endocrinology.

Celltrion USA, established in 2018 and headquartered in New Jersey, continues to leverage its biotechnology and manufacturing capabilities to provide high-quality biologic medicines in the U.S. market.