U.S. FDA approves Celltrion's OMLYCLO® (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR®

• OMLYCLO^® (omalizumab-igec)is the first and only omalizumab biosimilar approved by the FDA
• Regulatory approval for interchangeability was supported by positive phase III data demonstrating comparable efficacy and safety profile with the reference product XOLAIR^® (omalizumab)^[1]
• The availability of the first omalizumab biosimilar will help increase access and potentially lower the healthcare cost for people with asthma and allergic diseases

JERSEY CITY, N.J., March 9, 2025/PRNewswire/ -- Celltrion today announced the U.S. Food and Drug Administration (FDA) approved OMLYCLO^® (omalizumab-igec) as the first and only biosimilar designated as interchangeable with XOLAIR^® (omalizumab) 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).^[2] 

"We are proud to achieve the approval of the first biosimilar to omalizumab in the U.S., which will help broaden access to this important medicine for patients with allergic and respiratory conditions, as well as for physicians, payers and providers," said Hetal Patel, Vice President of Medical Affairs at Celltrion USA. "The interchangeability designation of OMLYCLO reinforces confidence among physicians and patients that there is no decrease in effectiveness or increase in safety risk associated with switching between OMLYCLO and the reference product."

The FDA approval and designation of interchangeability are based on comprehensive clinical evidence, including results from a global Phase III clinical trial involving 619 adult patients with CSU up to Week 40. Patients were randomized to receive 300 mg or 150 mg of OMLYCLO or reference product every 4 weeks. From Week 12, patients who received OMLYCLO were continued on OMLYCLO, and patients who received 300mg of the reference product were re-randomized in a 1:1 ratio to switch to OMLYCLO or to continue reference product. From Week 24, patients were followed up until Week 40 without dosing. The result demonstrated the comparable efficacy and safety of OMLYCLO to reference product during both treatment and off-dose periods.^[1]

An interchangeable biosimilar is a biosimilar that meets additional requirements outlined by the law that allows for the FDA to approve biosimilar and interchangeable biosimilar medications.^[3]

"The approval of OMLYCLO could have a meaningful impact for the medical community and patients, offering a high quality and affordable treatment option, while reducing the burden of healthcare costs," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "With our integrated development, manufacturing, and commercialization platform, Celltrion remains committed to alleviating treatment costs and delivering life-changing medicines to support patients with allergic conditions in the U.S."

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 and 150 mg/mL solution in a single-dose prefilled syringe is approved as interchangeable with reference product for all indications based on comprehensive data and clinical evidence confirming the therapeutic equivalence to XOLAIR.^[1],[2] OMLYCLO was also approved by the European Commission (EC) in May 2024.

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 OMLYCLO 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 symptoms, 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 this 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. Omalizumab increases serum total IgE due to drug:IgE complexes. Do not use serum total IgE levels within one year of discontinuation 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 ≥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 currently has nine biosimilar products approved by the U.S. FDA: INFLECTRA^® (infliximab-dyyb), TRUXIMA^® (rituximab-abbs), HERZUMA^® (trastuzumab-pkrb), VEGZELMA^® (bevacizumab-adcd), YUFLYMA^®(adalimumab-aaty), AVTOZMA^® (tocilizumab-anho), STEQEYMA^® (Ustekinumab-stba) STOBOCLO^® (denosumab-bmwo) and OSENVELT^® (denosumab-bmwo) as well as a 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

For further information please contact: 
Andria Arena
aarena@jpa.com
+1 516-578-0057

View original content to download multimedia:https://www.prnewswire.com/news-releases/us-fda-approves-celltrions-omlyclo-omalizumab-igec-as-the-first-and-only-biosimilar-with-interchangeability-designation-referencing-xolair-302396468.html

SOURCE Celltrion