Celltrion Launches Omlyclo Biosimilar in United States
The FDA-approved biosimilar for Xolair is now commercially available to treat asthma, food allergies, and other conditions.
Updated on Oct. 21, 2026 in Allergies
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Celltrion USA has released Omlyclo for commercial sale in the United States, providing a new interchangeable biosimilar to Xolair. The drug is authorized to treat multiple conditions, including persistent asthma, food allergies, chronic spontaneous urticaria, and nasal polyps.
Why it matters
The introduction of biosimilars increases market competition against established biologics, helping to lower overall costs for health systems and insurance plans. By being designated as interchangeable with Xolair, the drug can be substituted by pharmacists without requiring additional prescriber intervention in many cases.
The FDA approved Omlyclo in varying doses including 75 mg/0.5 mL, 150 mg/mL, and 300 mg/2 mL. Researchers conducted a phase 3 study of 619 patients to compare the efficacy and safety of the biosimilar against the reference product.
The players
Celltrion USA
This is a biopharmaceutical company that develops and markets biosimilar products to provide more affordable treatment options.
FDA
The Food and Drug Administration is the federal agency responsible for protecting public health by regulating pharmaceutical drugs and medical devices.
The details
Omlyclo is provided in single-dose prefilled syringes and is indicated for patients ranging from children as young as 1 year old for food allergies to adults for nasal polyps. Pharmacists may substitute the biosimilar for the reference biologic depending on specific state laws.
Timeline
March 2025: The FDA approved the initial 75 mg and 150 mg doses of Omlyclo.
December 2025: The FDA approved the 300 mg dose of Omlyclo.
October 21, 2026: Omlyclo became commercially available across the United States.
The Big Picture
This launch follows the framework established by the Biologics Price Competition and Innovation Act to increase market competition and access to lower-cost therapies.
Patients may now have access to a lower-cost, interchangeable treatment option for conditions like asthma and chronic hives. Individuals should consult their pharmacists or healthcare providers to determine if switching to the biosimilar is appropriate for their specific care plan.
The takeaway
Biosimilars are an increasingly important tool for reducing healthcare expenditures while maintaining clinical standards. Patients should discuss potential cost savings and medication adjustments with their pharmacists to understand the impact on their specific treatment regimen.
Further reading
For additional context on treatments for immune conditions, visit the United States Allergies section.
Source note: This article includes information reported by Healio.
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