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First Interchangeable Biosimilar for Asthma Launched

The U.S. launch of OMLYCLO offers a new option for patients managing asthma and several allergic conditions.

Updated on Oct. 5, 2026 in Allergies

Bold flat-color editorial illustration of a syringe, representing the launch of a new medical biosimilar.
Celltrion USA has launched OMLYCLO in the United States, the first FDA-approved interchangeable biosimilar to the biologic treatment XOLAIR. AI Illustration. Upload story photo >

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Celltrion USA has launched OMLYCLO, the first FDA-approved interchangeable biosimilar to XOLAIR, in the United States. This biologic treatment is now available to patients managing moderate to severe persistent asthma and various chronic allergic conditions.

Why it matters

The introduction of this biosimilar aims to increase access and affordability for patients who rely on biologic therapies to manage severe allergic reactions. By providing an interchangeable option, this launch offers a new pathway for patients and physicians to navigate treatment costs and availability.

OMLYCLO is the first interchangeable biosimilar approved by the FDA for conditions including moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, IgE-mediated food allergy, and chronic spontaneous urticaria.

The players

Celltrion USA

A pharmaceutical company based in Jersey City, N.J., that specializes in the development and distribution of biosimilar products.

XOLAIR

A reference biologic medication used to treat asthma, nasal polyps, and various food allergies.

The details

OMLYCLO is a biologic therapy administered via subcutaneous injection using single-dose prefilled syringes. As an interchangeable biosimilar, it has been shown to produce the same clinical result as its reference product in any given patient. Because the treatment carries a risk of anaphylaxis, administration must be performed under the observation of a healthcare provider, particularly during the initiation phase of therapy.

Timeline

  1. March 2025: The FDA granted approval for OMLYCLO.

  2. May 2024: The European Commission granted approval for OMLYCLO.

  3. October 5, 2026: OMLYCLO became commercially available in the United States.

Health Landscape

The arrival of OMLYCLO follows the FDA's biosimilar interchangeability designation, which establishes high standards for clinical equivalence between new products and established biologics. This development represents a shift toward more accessible biologic options for chronic immune-mediated conditions.

If you are currently prescribed biologic therapy for asthma or chronic hives, it is worth discussing with your doctor whether this new option might be appropriate for your treatment plan. Because of the risk of anaphylaxis, all patients must coordinate administration through their healthcare provider.

The takeaway

The arrival of a new biosimilar increases the range of options available for managing chronic allergic and asthmatic conditions. Patients should track how new treatment options affect their overall care costs and consult their physician regarding the safety requirements for administration.

Further reading

For more on how these treatments fit into a long-term care plan, visit our Allergies section.

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Do you believe the availability of biosimilar drugs makes your necessary medical treatments more affordable?