New Omlyclo Biosimilar Launches for Allergy Care

Patients with asthma and chronic allergies now have access to an interchangeable alternative to Xolair.

Updated on Oct. 21, 2026 in Allergies

Bold flat-color editorial illustration showing a single glass medicine ampoule, rendered in navy and cream with deep red accents. — Celltrion USA has launched Omlyclo, an FDA-approved interchangeable biosimilar for Xolair, aimed at reducing costs for patients managing chronic allergic conditions. AI Illustration. Upload story photo >

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Celltrion USA has launched Omlyclo, an FDA-approved biosimilar for Xolair, for commercial sale in the United States. The drug is authorized to treat conditions including persistent asthma, IgE-mediated food allergies, chronic spontaneous urticaria, and chronic rhinosinusitis with nasal polyps.

Why it matters

The introduction of this biosimilar brings competition to the established biologic market, which is designed to reduce costs for health plans and medical systems. Because it is interchangeable with Xolair, pharmacists may substitute the drug for the brand-name version in many states without requiring a new prescription.

A Phase 3 randomized trial evaluating 619 patients with chronic spontaneous urticaria compared the efficacy of Omlyclo against Xolair over a 40-week period, including 12 weeks of initial comparison and 24 weeks of efficacy evaluation. The safety and equivalence profiles are still under investigation.

The players

Celltrion USA

A pharmaceutical company specializing in the development and manufacturing of biosimilars.

Xolair

A well-known biologic medication used to treat moderate to severe persistent asthma and chronic hives.

The details

Omlyclo is provided in single-dose prefilled syringes in 75 mg/0.5 mL, 150 mg/mL, and 300 mg/2 mL doses. As an interchangeable biosimilar, it is designed to function biologically in the same way as Xolair to manage IgE-mediated conditions. The drug is approved for a broad range of patients, spanning from children aged 1 year and older for food allergies to adults for nasal polyps.

March 2025: The FDA approved the initial 75 mg/0.5 mL and 150 mg/mL doses of Omlyclo.
December 2025: The FDA approved the 300 mg/2 mL dose of Omlyclo.
October 21, 2026: Omlyclo became commercially available across the United States.

Health Landscape

The arrival of Omlyclo follows the rigorous regulatory pathways and interchangeability standards set by the FDA to ensure biosimilars match the efficacy and safety of their reference biologics. This launch continues the industry trend of introducing competitive alternatives for high-cost biologics to improve patient access.

If you currently use Xolair for asthma or allergies, you may see your pharmacist offer Omlyclo as a substitute at your next refill. It is worth discussing with your doctor or pharmacist whether this biosimilar is a suitable option for your ongoing care plan.

The takeaway

Omlyclo is now a clinically equivalent alternative to Xolair for patients managing persistent asthma, food allergies, and chronic hives. Patients should consult their physician or pharmacist to determine if this new biosimilar option aligns with their current treatment regimen.