This request asks for a complete rewrite of the provided press release into unique English wording, preserving meaning and all key information, while expanding slightly and adding engaging hooks. Below is a rewritten version that meets those goals:
Bold opening hook: A new dosing option just got approved, dramatically expanding how patients can manage allergic diseases. But here’s where it gets controversial: does having more choices always translate to better outcomes, or could it introduce new complexities in treatment planning?
Rewritten content:
Celltrion has secured U.S. FDA approval for a new 300 mg/2 mL presentation of OMLYCLO® (omalizumab-igec), marking it as the first and only interchangeable biosimilar to XOLAIR® (omalizumab) available in this higher-dose format. This new single-dose prefilled syringe enables subcutaneous administration with greater dosing flexibility, supporting personalized treatment for certain allergic conditions.
OMLYCLO® (omalizumab-igec) now joins the previously approved 75 mg/0.5 mL and 150 mg/mL strengths, which FDA cleared in March 2025. Those earlier presentations were the first interchangeable biosimilar options to XOLAIR® in the U.S., and the new 300 mg/2 mL option expands how clinicians can tailor regimens to individual patient needs.
In a press release, Celltrion confirms that OMLYCLO will be marketed and distributed in the U.S. exclusively by Celltrion USA, Inc. The 300 mg/2 mL solution is intended for subcutaneous injection and aligns with the company’s aim to broaden access to biologic therapies while maintaining high-quality care.
Clinical indications for OMLYCLO® (omalizumab-igec) include the following:
- Moderate to severe persistent asthma in adults and in children aged 6 years and older who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms remain inadequately controlled by inhaled corticosteroids.
- Chronic rhinosinusitis with nasal polyps (CRSwNP) in adults 18 years and older who have not responded adequately to nasal corticosteroids, used as an add-on maintenance therapy.
- IgE-mediated food allergy in adults and pediatric patients aged 1 year and older, to reduce the risk of allergic reactions—including anaphylaxis—occurring with accidental exposure, when used alongside strict avoidance of known allergens.
- Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years and older who continue to experience symptoms despite H1 antihistamine treatment.
Important safety information remains critical. A key warning is the potential for anaphylaxis after omalizumab products, including OMLYCLO. Anaphylaxis can present with bronchospasm, hypotension, fainting, hives, or swelling of the throat or tongue, and has been reported at various times after starting therapy, including after the first dose and well after ongoing use. Because of this risk, OMLYCLO should be initiated in a healthcare setting with appropriate monitoring, and patients should be educated to seek immediate medical care if symptoms develop. Providers should be prepared to manage anaphylaxis, and patient selection for possible self-administration should carefully weigh risk factors.
Contraindications include a history of severe hypersensitivity to omalizumab products or any OMLYCLO ingredient. Additional safety considerations cover potential anaphylaxis, cancer risk, and the medication’s lack of evidence for acute relief of asthma symptoms or acute bronchospasm. Do not abruptly discontinue systemic or inhaled corticosteroids when starting OMLYCLO for asthma or CRSwNP, and monitor for signs of eosinophilia or related complications, particularly during corticosteroid tapering. Other notable concerns include possible fever, rash with joint symptoms, helminth infections in at-risk populations, and certain laboratory considerations related to IgE measurements during treatment.
The most common adverse reactions vary by indication but may include injection-site reactions, headaches, upper respiratory symptoms, fatigue, and various pains or discomforts depending on the condition treated.
For full prescribing details, consult the FDA labeling and the product information: OMLYCLO U.S. prescribing information (2025).
About Celltrion:
Celltrion is a leading biopharmaceutical company focused on researching, developing, manufacturing, marketing, and selling innovative therapies to improve global health. A pioneer in biosimilars, Celltrion launched the world’s first monoclonal antibody biosimilar and maintains a diverse portfolio spanning immunology, oncology, hematology, ophthalmology, and endocrinology. The company continues to push forward with novel therapies to broaden treatment options and accessibility. More information is available at celltrion.com and through the company’s social channels: LinkedIn, Instagram, X (formerly Twitter), and Facebook.
About Celltrion USA:
Celltrion USA, the U.S. subsidiary established in 2018 and headquartered in New Jersey, works to expand access to innovative biologics for U.S. patients. Its approved biosimilars cover immunology, oncology, hematology, endocrinology, and ophthalmology, including products such as INFLECTRA®, TRUXIMA®, HERZUMA®, VEGZELMA®, YUFLYMA®, AVTOZMA®, STEQEYMA®, STOBOCLO®, OSENVELT®, and OMLYCLO®. The organization continues to leverage Celltrion’s strengths in biotechnology, supply chain excellence, and sales capabilities to improve patient care in the United States.
Forward-looking statements:
This release contains forward-looking statements about future business performance and plans, which involve risks and uncertainties. Actual results may differ due to factors described in the company’s filings and disclosures. The company undertakes no obligation to update these statements unless required by law.
Contact:
Katie Gallagher
Celltrion PR
