Bold claim: A new injectable option now expands how doctors can tailor allergy and inflammatory disease treatment, but the debate over interchangeable biosimilars remains. Here's a fully rewritten, user-friendly version of the original announcement that preserves all key information while clarifying the details and adding accessible explanations.
Celltrion has announced that the U.S. FDA has approved a new 300 mg/2 mL presentation of OMLYCLO® (omalizumab-igec). This makes it the first and only biosimilar to XOLAIR® (omalizumab) designated as interchangeable, offering a single-dose prefilled syringe for subcutaneous injection. In the United States, OMLYCLO will be distributed exclusively by Celltrion USA, Inc.
Previously, in March 2025, the FDA approved two other OMLYCLO strengths—75 mg/0.5 mL and 150 mg/mL—also in single-dose prefilled syringes for subcutaneous use. These formulations were approved for treating several allergic and inflammatory conditions, including moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), IgE-mediated food allergy, and chronic spontaneous urticaria (CSU).
Dr. Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion USA, emphasized that the new 300 mg option broadens dosing flexibility and helps tailor treatment to individual patient needs. The addition of this higher-dose presentation can reduce the number of injections patients must receive and lessen the overall burden and discomfort associated with ongoing therapy.
Thomas Nusbickel, Chief Commercial Officer at Celltrion USA, highlighted that expanding dosing options reinforces Celltrion’s commitment to improving access to biologic therapies in the U.S. He noted ongoing efforts to support physicians with flexible, high-quality treatment options so more patients can benefit from advanced care.
About OMLYCLO® (omalizumab-igec)
OMLYCLO® is the first FDA-approved anti-IgE antibody biosimilar referencing XOLAIR®. The product line includes 75 mg/0.5 mL, 150 mg/mL, and 300 mg/2 mL solutions in single-dose prefilled syringes, all designated as interchangeable with the reference product based on comprehensive data showing therapeutic equivalence to XOLAIR. Regulatory approval for OMLYCLO occurred from the FDA in March 2025 and from the European Commission in May 2024.
Indications
OMLYCLO® (omalizumab-igec) is indicated for:
- Moderate to severe persistent asthma in adults and pediatric patients aged 6 years and older with a positive skin test or in vitro reactivity to perennial aeroallergens, whose symptoms remain inadequately controlled despite inhaled corticosteroids
- Chronic rhinosinusitis with nasal polyps (CRSwNP) in adults 18 years and older who have not adequately responded to nasal corticosteroids, as add-on maintenance therapy
- IgE-mediated food allergy in adults and pediatric patients aged 1 year and older, to reduce allergic reactions (Type I) including potential anaphylaxis with accidental exposure, used together with food allergen avoidance
- Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years and older who remain symptomatic despite H1 antihistamine treatment
Limitations: OMLYCLO is not indicated for acute bronchospasm or status asthmaticus, nor for emergency treatment of allergic reactions, including anaphylaxis. It should not be used to treat acute asthma symptoms, and abrupt corticosteroid withdrawal is not advised when starting OMLYCLO for asthma or CRSwNP.
Important Safety Information
Warning: Anaphylaxis has been reported with omalizumab products, including OMLYCLO. Reactions can occur after any dose, even after long-term use. Initiate therapy in a healthcare setting with observation after administration, and be prepared to manage anaphylaxis. Screening and patient selection for self-administration should consider the risk, and patients should be informed about signs of anaphylaxis and seek immediate care if symptoms occur.
Contraindications: Known severe hypersensitivity to omalizumab or any ingredient in OMLYCLO.
Additional safety considerations include potential malignancies, lack of control of acute asthma symptoms, eosinophilic conditions, signs of systemic reactions (fever, rash, arthralgia), and the need for monitoring certain lab parameters due to changes in IgE levels. OMLYCLO is intended as maintenance therapy to reduce allergic reactions and should be used as part of a broader management plan including avoidance of known allergens.
Adverse Reactions: Common adverse events vary by condition treated and age group, including injection-site reactions, headaches, throat and nasal symptoms, fatigue, dizziness, and upper respiratory infections. Specific lists of expected adverse events are provided in the full prescribing information.
For more details, refer to the full prescribing information: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761399s000lbl.pdf
About Celltrion
Celltrion focuses on researching, developing, manufacturing, marketing, and selling innovative therapies that aim to improve patient outcomes worldwide. A pioneer in biosimilars, Celltrion has introduced the world’s first monoclonal antibody biosimilar and maintains a diverse portfolio spanning immunology, oncology, hematology, ophthalmology, and endocrinology. The company also pursues new drug development to push the boundaries of scientific innovation.
Celltrion USA
Celltrion USA, the U.S. subsidiary established in 2018 and headquartered in New Jersey, works to broaden patient access to cutting-edge biologics. The U.S. portfolio includes multiple biosimilars across immunology, oncology, hematology, endocrinology, and ophthalmology, with ongoing efforts to expand access to high-quality biologics for U.S. patients.
Forward-Looking Statements
This release contains forward-looking statements about future business performance and product plans, which involve risks and uncertainties. Actual results may differ due to various factors outlined in regulatory filings and public disclosures. Celltrion undertakes no obligation to update these statements unless required by law.
Contemporary context and questions for readers
- The designation of an interchangeable biosimilar suggests specific regulatory assurances about automatic substitution and comparability to XOLAIR. Do you see this as a meaningful improvement in access to therapy, or do you have concerns about interchangeability in clinical practice?
- Higher-dose options can reduce injection frequency, but what are your thoughts on patient acceptance and adherence with more concentrated formulations?
- With the ongoing discussion about biosimilars and market competition, how should physicians balance cost, access, and assurance of therapeutic equivalence when choosing between XOLAIR and OMLYCLO?
If you’d like, this rewritten version can be tailored further for a specific audience (patients, healthcare professionals, investors) or adapted into a concise press release with bullet-point highlights. Would you prefer a patient-focused version that emphasizes practical usage and safety tips, or a professional brief with clinical and regulatory context?
