Celltrion Launches a Biosimilar Designated as Interchangeable with Omalizumab (Xolair)

Omalizumab-igec (Omlyclo, Celltrion), a biosimilar designated as interchangeable with omalizumab (Xolair), is now commercially available in the US, Celltrion USA announced in a press release. The company described it as the first and only FDA-approved interchangeable biosimilar to Xolair.

The anti-IgE antibody is approved for all 4 Xolair indications. The FDA approved omalizumab-igec in March 2025, and the European Commission approved it in May 2024. It is available as 75mg/0.5mL, 150mg/mL, and 300mg/2mL single-dose prefilled syringes for subcutaneous injection.

Omalizumab-igec is indicated for moderate to severe persistent asthma in patients 6 years and older with perennial aeroallergen reactivity whose symptoms are inadequately controlled with inhaled corticosteroids; as add-on maintenance treatment for chronic rhinosinusitis with nasal polyps in adults with inadequate response to nasal corticosteroids; for IgE-mediated food allergy in patients 1 year and older, to reduce allergic reactions from accidental exposure, alongside allergen avoidance; and for chronic spontaneous urticaria in patients 12 years and older who remain symptomatic despite H1 antihistamine treatment. According to Celltrion, interchangeability was based on data confirming therapeutic equivalence to Xolair, including a randomized, double-blind phase 3 study in chronic spontaneous urticaria.

The labeling carries a boxed warning for anaphylaxis, which has occurred after the first dose and beyond 1 year of treatment. Therapy is to be initiated in a healthcare setting with close observation afterward. Malignancies have been observed in clinical studies, and the long-term risk is unknown, according to the safety information. The biosimilar is not indicated for acute bronchospasm, status asthmaticus, or emergency treatment of allergic reactions.

Dr. Juby Jacob-Nara, senior vice president and chief medical officer at Celltrion USA, said the biosimilar offers "a new opportunity to improve affordability and expand access."

Source: Celltrion USA. Omlyclo (omalizumab-igec), the first and only FDA-approved interchangeable biosimilar to Xolair, now commercially available in the US. Press release. Celltrion USA; October 5, 2026. Accessed October 6, 2026.