FDA Approves First Interchangeable Biosimilar for Omalizumab

The US Food and Drug Administration (FDA) has approved omalizumab-igec (OMLYCLO) as the first interchangeable biosimilar for reference omaliumab (Xolair) and the first respiratory biosimilar, for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), Immunoglobulin E (IgE)-mediated food allergy, and chronic spontaneous urticaria (CSU).1

"We are proud to achieve the approval of the first biosimilar to omalizumab in the U.S., which will help broaden access to this important medicine for patients with allergic and respiratory conditions, as well as for physicians, payers and providers," Hetal Patel, vice president of medical affairs at Celltrion USA, said in a statement.1 "The interchangeability designation of OMLYCLO reinforces confidence among physicians and patients that there is no decrease in effectiveness or increase in safety risk associated with switching between OMLYCLO and the reference product."

Omalizumab-igec has been approved in 2 dosage forms matching the reference formulations: a 75 mg/0.5 mL injection and a 150 mg/mL injection, both to be administered in single-dose prefilled syringes for subcutaneous use.

The approval, and interchangeability designation, was based on results from a double-blind, randomized, active-controlled, parallel group, phase 3 study (NCT04426890) which confirmed the bioequivalence of omalizumab-igec to Xolair in patients with CSU.2 The trial, conducted in 6 countries, including Poland and Bulgaria, involved 619 patients with CSU. CT-P39 demonstrated similar results to Xolair in terms of efficacy, safety, pharmacokinetics, and immunogenicity, meeting the pre-defined equivalence criteria.

"The approval of OMLYCLO could have a meaningful impact for the medical community and patients, offering a high quality and affordable treatment option, while reducing the burden of healthcare costs," Thomas Nusbickel, chief commercial officer at Celltrion USA, added.1 "With our integrated development, manufacturing, and commercialization platform, Celltrion remains committed to alleviating treatment costs and delivering life-changing medicines to support patients with allergic conditions in the U.S."

Notably, the biosimilar’s approval may expand access and allow cost savings for patients with food allergy that may benefit from omalizumab’s most recent approval for treating food allergy after accidental exposure.3 The biologic became the first FDA-approved medication to reduce allergic reactions to more than one type of food after accidental exposure in February 2024.

Omalizumab-igec’s biologic license application approval also includes labeling for an unbranded biological version, expanding access to more patients. This dual-pricing strategy is utilized by other biosimilars in chronic disease spaces, such as the insulin glargine and adalimumab markets.4

REFERENCES

1. U.S. FDA approves Celltrion's OMLYCLO® (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR®. News release. Celltrion. March 9, 2025. Accessed March 10, 2025. https://www.prnewswire.com/news-releases/us-fda-approves-celltrions-omlyclo-omalizumab-igec-as-the-first-and-only-biosimilar-with-interchangeability-designation-referencing-xolair-302396468.html

2. Celltrion confirms bioequivalence for CT-P39 against Xolair in interim results of phase 3 study. Korea Biomedical Review. Published April 10, 2024. Accessed March 10, 2025. https://www.koreabiomed.com/news/articleView.html?idxno=20848

3. FDA Approves First Medication to Help Reduce Allergic Reactions to Multiple Foods After Accidental Exposure. February 16, 2024. Accessed March 10, 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-first-medication-help-reduce-allergic-reactions-multiple-foods-after-accidental

4. Jeremias S. Happy birthday adalimumab biosimilars: reflecting on the first year of US competition. The Center for Biosimilars. January 31, 2024. Accessed March 10, 2025. https://www.centerforbiosimilars.com/view/happy-birthday-adalimumab-biosimilars-reflecting-on-the-first-year-of-us-competition