FDA Approves Higher-Dose Omlyclo® Biosimilar, Expanding Treatment Options for Allergic Conditions
The Food and Drug Administration (FDA) has granted approval for a new 300mg/2mL single-dose prefilled syringe presentation of Omlyclo® (omalizumab-igec), an interchangeable biosimilar to Xolair® (omalizumab). This expanded offering aims to provide greater flexibility and convenience for patients managing a range of allergic and inflammatory diseases.
The approval broadens access to omlyclo, which was initially approved in March 2025 in 75mg/0.5mL and 150mg/mL strengths. Omlyclo is an anti-immunoglobulin E (IgE) antibody indicated for several conditions:
- Asthma: Moderate to severe persistent asthma in adults and children aged 6 years and older with confirmed allergies and inadequate symptom control with inhaled corticosteroids.
- Chronic Rhinosinusitis: Chronic rhinosinusitis with nasal polyps in adults 18 years and older who have not responded sufficiently to nasal corticosteroids.
- Food Allergy: IgE-mediated food allergy in patients aged 1 year and older, reducing the risk of allergic reactions – including anaphylaxis – from accidental food exposure, when used alongside allergen avoidance.
- Urticaria: Chronic spontaneous urticaria in adults and adolescents 12 years and older who continue to experience symptoms despite treatment with H1 antihistamines.
According to a company release, the addition of the 300mg presentation demonstrates a commitment to patients in the United States. “The approval of the additional 300mg presentation of Omlyclo underscores our dedication to patients in the US, by broadening treatment choices and expanding flexibility, addressing diverse needs of patients with allergic and inflammatory conditions,” stated Dr. Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion USA. “The new dosing option of Omlyclo can help reduce the number of required injections and ease the overall treatment burden and discomfort for patients with these diseases.”
The higher dose is expected to simplify treatment regimens for some patients, potentially reducing the frequency of injections. This could significantly improve adherence and quality of life for individuals managing chronic allergic conditions.
This approval further solidifies the role of biosimilars in expanding access to vital medications. Biosimilars, like Omlyclo, are highly similar to existing biologic drugs but are typically more affordable, offering a cost-effective alternative for patients and healthcare systems.
The FDA’s decision is based on data demonstrating the biosimilarity of Omlyclo to Xolair, ensuring comparable safety and efficacy.
References:
Celltrion announces US FDA approval of 300mg strength of Omlyclo® (omalizumab-igec), the first and only FDA-approved interchangeable biosimilar to Xolair®. News release. Celltrion. December 2, 2025. https://www.prnewswire.com/news-releases/celltrion-announces-us-fda-approval-of-300mg-strength-of-omlyclo-omalizumab-igec-the-first-and-only-fda-approved-interchangeable-biosimilar-to-xolair-302631123.html.
