On Mar. 9, 2025, Celltrion announced the U.S. Food and Drug Administration (FDA) approved OMLYCLO^® (omalizumab-igec) as the first and only biosimilar designated as interchangeable with XOLAIR^® (omalizumab) 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).

The FDA approval and designation of interchangeability are based on comprehensive clinical evidence, including results from a global Phase III clinical trial involving 619 adult patients with CSU up to Week 40. Patients were randomized to receive 300 mg or 150 mg of OMLYCLO or reference product every 4 weeks. From Week 12, patients who received OMLYCLO were continued on OMLYCLO, and patients who received 300mg of the reference product were re-randomized in a 1:1 ratio to switch to OMLYCLO or to continue reference product. From Week 24, patients were followed up until Week 40 without dosing. The result demonstrated the comparable efficacy and safety of OMLYCLO to reference product during both treatment and off-dose periods.

An interchangeable biosimilar is a biosimilar that meets additional requirements outlined by the law that allows for the FDA to approve biosimilar and interchangeable biosimilar medications.

OMLYCLO^® (omalizumab-igec) is the first U.S. Food and Drug Administration (FDA)-approved anti-IgE antibody biosimilar referencing XOLAIR^® (omalizumab). OMLYCLO 75 mg/0.5 mL and 150 mg/mL solution in a single-dose prefilled syringe is approved as interchangeable with reference product for all indications based on comprehensive data and clinical evidence confirming the therapeutic equivalence to XOLAIR^. OMLYCLO was also approved by the European Commission (EC) in May 2024.

Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people’s lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world’s first monoclonal antibody biosimilar.