Bold claim: A new 300 mg dose of OMLYCLO® (omalizumab-igec) has been approved by the U.S. FDA as an interchangeable biosimilar to XOLAIR®, expanding options for patients with allergic diseases. This development increases dosing flexibility and supports personalized treatment plans for individuals with specific conditions.
Key points:
- The FDA has authorized OMLYCLO® (omalizumab-igec) 300 mg/2 mL in a single-dose prefilled syringe for subcutaneous injection. This marks the first and only interchangeable biosimilar to XOLAIR®. Previously, in March 2025, the agency approved OMLYCLO® 75 mg/0.5 mL and 150 mg/mL formulations in single-dose prefilled syringes.
- In the United States, Celltrion USA will exclusively market and distribute OMLYCLO®. The product is positioned to help clinicians tailor regimens according to patient needs.
Context and background:
- In March 2025, the FDA approved OMLYCLO® for several indications, including moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), IgE-mediated food allergy, and chronic spontaneous urticaria (CSU).
- The 300 mg presentation broadens dosing options and aims to reduce injection frequency and overall treatment burden for patients with these allergic and inflammatory diseases.
Executive quotes:
- Dr. Juby Jacob-Nara, Senior VP and Chief Medical Officer at Celltrion USA, emphasizes that the additional 300 mg option broadens treatment choices and can lower the number of injections, easing the treatment burden for patients.
- Thomas Nusbickel, Chief Commercial Officer at Celltrion USA, highlights the milestone of expanding dosing options and reiterates commitment to flexible, high-quality treatments to improve patient access to care.
About OMLYCLO® (omalizumab-igec):
- OMLYCLO® is the first FDA-approved anti-IgE antibody biosimilar referencing XOLAIR® (omalizumab) and has demonstrated therapeutic equivalence to XOLAIR based on comprehensive data.
- Approved formulations include 75 mg/0.5 mL, 150 mg/mL, and 300 mg/2 mL, all in single-dose prefilled syringes and designated as interchangeable with XOLAIR® for approved indications.
- Regulatory approvals were granted by the FDA and the European Commission (EC) in 2025 and 2024, respectively.
Indications (summary):
- Moderate to severe persistent asthma in adults and children aged 6 years and older with documented sensitivity to perennial aeroallergens and inadequate control on inhaled corticosteroids.
- CRSwNP in adults 18 and older with insufficient response to nasal corticosteroids, as add-on maintenance therapy.
- IgE-mediated food allergy in individuals aged 1 year and older to reduce reactions (including anaphylaxis) with accidental exposure, alongside allergen avoidance.
- CSU in adults and adolescents 12 years and older who remain symptomatic despite H1 antihistamines.
Important safety information and warnings:
- Warning: Anaphylaxis has been reported with omalizumab products, including OMLYCLO. Reactions can occur after the first dose or even after long-term use. Initiate therapy in a healthcare setting with monitoring and have emergency management readiness.
- Contraindication: Severe hypersensitivity to omalizumab or any OMLYCLO ingredient.
- Other safety considerations include potential malignancies, lack of acute relief for asthma exacerbations, risks related to eosinophilic conditions, and monitoring needs for specific patient populations.
- Routine laboratory and monitoring considerations include avoiding reliance on total IgE levels within one year after discontinuation to adjust dosing, due to possible drug-IgE complexes.
Adverse reactions (selected):
- Asthma (6–11 years and older): various symptoms including arthralgia, fatigue, dizziness, and injection-site reactions.
- CRSwNP: headaches, injection-site reactions, arthralgia, and dizziness.
- IgE-mediated food allergy: injection-site reactions and fever.
- CSU: nausea, nasopharyngitis, sinusitis, and upper respiratory infections.
Regulatory and company information:
- Celltrion, a biopharmaceutical company focused on biosimilars and innovative therapeutics across immunology, oncology, hematology, ophthalmology, and endocrinology.
- Celltrion USA, established in 2018 and based in New Jersey, oversees U.S. distribution for OMLYCLO® and other biosimilars.
- For full prescribing details and safety information, refer to the official labeling and prescribing resources.
Forward-looking note:
- This press release includes forward-looking statements about future business performance and product availability. These statements are subject to risks and uncertainties and may not come to pass.
Would you like to explore a comparison of the 300 mg dose with the 75 mg/0.5 mL and 150 mg/mL options in terms of patient suitability, administration schedules, and potential cost implications? Also, would a brief section added with real-world patient scenarios help illustrate how clinicians might choose between dosing regimens?
