Celltrion announces U.S. FDA approval of 300mg strength of OMLYCLO® (omalizumab-igec), the first and only FDA-approved interchangeable biosimilar to XOLAIR®

• FDA approval of OMLYCLO^® (omalizumab-igec) 300 mg/2 mL solution in a single-dose prefilled syringe for subcutaneous injection expands dosing flexibility and supports tailored treatment for individual patients with certain allergic diseases
• OMLYCLO^® (omalizumab-igec) is the first and only biosimilar designated as interchangeable with XOLAIR^® (omalizumab); The FDA previously approved OMLYCLO^® 75 mg/0.5 mL and 150 mg/mL in a single-dose prefilled syringe for subcutaneous injection in March 2025

INCHEON, South Korea, Dec. 1, 2025 /PRNewswire/ -- Celltrion, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved a new presentation of OMLYCLO^® (omalizumab-igec), the first and only biosimilar designated as interchangeable with XOLAIR^® (omalizumab), in a 300mg/2mL solution in a single-dose prefilled syringe for subcutaneous injection. In the U.S., OMLYCLO will be marketed and distributed exclusively by Celltrion USA, Inc.

In March 2025, the FDA approved OMLYCLO in 75 mg/0.5 mL and 150 mg/mL solutions in a single-dose prefilled syringe for subcutaneous injection for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), Immunoglobulin E (IgE)-mediated food allergy, and chronic spontaneous urticaria (CSU).^[1]

"The approval of the additional 300 mg presentation of OMLYCO underscores our dedication to patients in the U.S., by broadening treatment choices and expanding flexibility, addressing diverse needs of patients with allergic and inflammatory conditions," said 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."

"We are proud of the expansion of OMLYCLO's dosing options, marking another significant milestone in our commitment to increasing access to biologic treatments in the U.S.," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "We remain steadfast in our efforts to support physicians with flexible, high-quality treatment options and ensure that more patients can benefit from best-in-class care."

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About OMLYCLO^® (omalizumab-igec)  

OMLYCLO^® (omalizumab-igec) is the first U.S. Food and Drug Administration (FDA)-approved anti-IgE antibody biosimilar referencing XOLAIR^® (omalizumab). OMLYCLO 75 mg/0.5 mL, 150 mg/mL and 300 mg/2mL solutions in a single-dose prefilled syringe is approved as interchangeable with the reference product for all indications based on comprehensive data and clinical evidence confirming the therapeutic equivalence to XOLAIR.^[1] OMLYCLO was approved by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) in March 2025 and May 2024, respectively.

INDICATION

OMLYCLO^® (omalizumab-igec) injection, is an anti-IgE antibody indicated for: 

• Moderate to severe persistent asthma in adults and pediatric patients ≥6 years of age with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids
• Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients ≥18 years of age with inadequate response to nasal corticosteroids, as add-on maintenance treatment
• IgE-mediated food allergy in adult and pediatric patients aged ≥1 year age for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjunction with food allergen avoidance
• Chronic spontaneous urticaria (CSU) in adults and adolescents ≥12 years of age who remain symptomatic despite H1 antihistamine treatment

Limitations of Use: Not indicated for: acute bronchospasm or status asthmaticus; emergency treatment of allergic reactions, including anaphylaxis; other forms of urticaria.

IMPORTANT SAFETY INFORMATION

WARNING: ANAPHYLAXIS

Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of omalizumab products. Anaphylaxis has occurred as early as after the first dose of omalizumab products, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, initiate OMLYCLO therapy in a healthcare setting and closely observe patients for an appropriate period of time after OMLYCLO administration.

Health care providers administering OMLYCLO should be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur. Selection of patients for self-administration of OMLYCLO should be based on criteria to mitigate risk from anaphylaxis.

Contraindications: Severe hypersensitivity reaction to omalizumab products or any ingredient of OMLYCLO.

Anaphylaxis. Omalizumab products, including OMLYCLO, have been associated with anaphylaxis, reported in both clinical trials and postmarketing data. Patients with a history of anaphylaxis to foods, medications, or other causes face an increased risk. Initiate OMLYCLO only in a healthcare setting with anaphylaxis management capabilities. Patients should be monitored for an appropriate period post-administration, informed of signs and symptoms of anaphylaxis, and instructed to seek immediate medical care if they occur.

Malignancy. Malignancies have been observed in clinical studies, with various cancer types reported. The long-term risk, especially in high-risk groups, is unknown.

Acute Asthma Symptoms and Deteriorating Disease. Omalizumab products have not been shown to alleviate asthma exacerbations acutely. Do not use OMLYCLO to treat acute bronchospasm or status asthmaticus.

Corticosteroid Reduction. Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of OMLYCLO therapy for asthma or CRSwNP.

Eosinophilic Conditions. Be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy, especially upon reduction of oral corticosteroids.

Fever, Arthralgia, and Rash. Stop OMLYCLO if a patient develops a constellation of signs and symptoms, including arthritis/arthralgia, rash, fever, and lymphadenopathy.

Parasitic (Helminth) Infection. Monitor patients at high risk of geohelminth infection while on OMLYCLO therapy.

Laboratory Tests. Administration of omalizumab products increases serum total IgE due to drug:IgE complexes. Do not use serum total IgE levels within one year of discontinuation of omalizumab products to reassess dosing regimen, as they may not reflect steady-state free IgE.

Potential Medication Error Related to Emergency Treatment of Anaphylaxis. OMLYCLO should not be used for the emergency treatment of allergic reactions, including anaphylaxis. Instruct patients that OMLYCLO is for maintenance use to reduce allergic reactions, including anaphylaxis, while avoiding food allergens.

Most Common Adverse Reactions

• Asthma: In patients ≥12 years, reported in ≥1%: arthralgia, general pain, leg pain, fatigue, dizziness, fracture, arm pain, pruritus, dermatitis, and earache. In pediatric patients (6 to <12 years), reported in ≥3%: nasopharyngitis, headache, pyrexia, upper abdominal pain, streptococcal pharyngitis, otitis media, viral gastroenteritis, arthropod bites, and epistaxis.
• CRSwNP: In patients ≥3% of adults: headache, injection site reactions, arthralgia, upper abdominal pain, and dizziness.
• IgE-Mediated Food Allergy: In ≥3% of patients: injection site reactions and pyrexia.
• CSU: In ≥2% of patients: nausea, nasopharyngitis, sinusitis, upper respiratory tract infections (viral and non-viral), arthralgia, headache, and cough.

For more information, see Full Prescribing Information.

About Celltrion

Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us. and stay updated with our latest news and events on our social media: LinkedIn, Instagram, X, and Facebook.

About Celltrion USA

Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion's FDA-approved biosimilar products in immunology, oncology, hematology,  endocrinology and ophthalmology include: INFLECTRA^® (infliximab-dyyb), TRUXIMA^® (rituximab-abbs), HERZUMA^® (trastuzumab-pkrb), VEGZELMA^® (bevacizumab-adcd), YUFLYMA^®(adalimumab-aaty), AVTOZMA^® (tocilizumab-anho), STEQEYMA^® (ustekinumab-stba) STOBOCLO^® (denosumab-bmwo), OSENVELT^® (denosumab-bmwo), OMLYCLO^® (omalizumab-igec), and EYDENZELT^® (aflibercept-boav), as well as the novel biologic ZYMFENTRA^® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit www.celltrionusa.com and stay updated with our latest news and events on our social media - LinkedIn.

FORWARD-LOOKING STATEMENT

Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws.

These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", the negative of these words or such other variations thereon or comparable terminology.

In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries' management, of which many are beyond its control.

Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect to the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.

Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements.

Celltrion Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws.

Trademarks

OMLYCLO^® is a registered trademark of CELLTRION, Inc.
XOLAIR^® is a registered trademark of Novartis AG.

References

US-OML-25-00005

For further information please contact:
Katie Gallagher
[email protected] 
+1 617-657-1324

SOURCE Celltrion