Celltrion Launched OMLYCLO Biosimilar in U.S.

The interchangeable biosimilar to XOLAIR is now available for patients managing severe asthma and food allergies.

Updated on Oct. 5, 2026 in Allergies

Isometric editorial illustration of a glass syringe and vial on a clinical surface, representing the launch of a new biosimilar medication. — Celltrion USA has launched OMLYCLO, the first FDA-approved interchangeable biosimilar to XOLAIR, aimed at increasing access to treatments for severe asthma and allergies. AI Illustration. Upload story photo >

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Celltrion USA has initiated the commercial availability of OMLYCLO, marking the first FDA-approved interchangeable biosimilar to XOLAIR. This rollout aims to expand patient access to essential biologic treatments for various allergic and inflammatory conditions.

Why it matters

The introduction of this biosimilar is designed to increase affordability and broaden the availability of biologic therapies for patients living with chronic conditions. It provides a new treatment option for those managing complex immunological responses.

OMLYCLO is available in three prefilled syringe dosages: 75 mg/0.5 mL, 150 mg/mL, and 300 mg/2 mL. These formulations are indicated for moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, IgE-mediated food allergy, and chronic spontaneous urticaria.

The players

Celltrion USA

Headquartered in Jersey City, N.J., this company is the American subsidiary of a global biopharmaceutical firm focused on biosimilars.

The details

The medication is administered through subcutaneous injection, with therapy initiation requiring observation in a healthcare setting to monitor for potential anaphylaxis. OMLYCLO is authorized for a range of conditions including chronic spontaneous urticaria and IgE-mediated food allergy.

March 2025: OMLYCLO received FDA approval.
May 2024: OMLYCLO received European Commission approval.
October 5, 2026: OMLYCLO became commercially available in the U.S.

Health Landscape

This release follows the regulatory path established by the FDA's Biosimilar Interchangeability designation to provide alternatives to high-cost biologic drugs. The shift reflects a growing industry emphasis on using interchangeable biosimilars to reduce long-term treatment costs.

Patients may find increased accessibility to their prescribed biologic treatments through this new biosimilar option. Individuals should consult their healthcare providers to discuss if transitioning to OMLYCLO is appropriate for their specific treatment plan.

The takeaway

The arrival of OMLYCLO provides patients and providers with a verified alternative for managing severe asthma and allergic conditions. It emphasizes the importance of clinical supervision during therapy initiation to ensure patient safety when switching between biologics.