Celltrion Secures FDA Approval for OMLYCLO® 300 mg, First Interchangeable Biosimilar to XOLAIR
Celltrion has announced U.S. FDA approval of a new 300 mg/2 mL prefilled syringe presentation of OMLYCLO® (omalizumab-igec), the first and only biosimilar designated as interchangeable with XOLAIR® (omalizumab).
This expands dosing flexibility and allows tailored treatment for patients with certain allergic and inflammatory conditions.
Previously, in March 2025, the FDA approved OMLYCLO® in 75 mg/0.5 mL and 150 mg/mL single-dose prefilled syringes for subcutaneous injection for indications including moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), IgE-mediated food allergy, and chronic spontaneous urticaria (CSU).
The new 300 mg option is expected to reduce the number of required injections, easing the treatment burden for patients.
OMLYCLO® has been approved based on comprehensive clinical data demonstrating therapeutic equivalence to XOLAIR® and is interchangeable with the reference product for all indications.
OMLYCLO® is indicated for moderate to severe persistent asthma in adults and children aged six years and older whose symptoms are inadequately controlled with inhaled corticosteroids, for chronic rhinosinusitis with nasal polyps in adults with insufficient response to nasal corticosteroids, for IgE-mediated food allergy in patients aged one year and older to reduce allergic reactions including anaphylaxis in conjunction with food allergen avoidance, and for chronic spontaneous urticaria in patients aged 12 years and older who remain symptomatic despite H1 antihistamine treatment.
It is not indicated for acute bronchospasm, status asthmaticus, emergency treatment of allergic reactions, or other forms of urticaria.
