Celltrion to Present New Analyses of OMLYCLO® (omalizumab-igec) in Chronic Spontaneous Urticaria at ACAAI 2026

• Post hoc analyses of the Phase 3 study of CT-P39 (omalizumab-igec) found that improvements in quality of life, as assessed by the Dermatology Life Quality Index, emerged earlier than disease activity responses, with 41.7% of patients maintaining disease control and quality of life up to 16 weeks after treatment ended
• Additional analyses showed comparable efficacy between CT-P39 and reference omalizumab regardless of baseline itch severity, and comparable pharmacokinetics in patients with comorbid asthma, respectively
• Data follow the recent U.S. launch of OMLYCLO, the first and only FDA-approved interchangeable biosimilar to XOLAIR^® (omalizumab)

JERSEY CITY, N.J., Nov. 12, 2026 /PRNewswire/ -- Celltrion USA, Inc. today announced that three post hoc analyses from the Phase 3 study of OMLYCLO^® (omalizumab-igec; CT-P39) in chronic spontaneous urticaria (CSU) will be presented as posters on Nov. 14 and 15 at the American College of Allergy, Asthma and Immunology (ACAAI) 2026 Annual Scientific Meeting in Phoenix, Arizona.

One analysis examines the relationship between CSU disease activity and quality of life (QoL) during omalizumab treatment, and a second evaluates outcomes according to baseline itch severity. A separate post hoc subgroup analysis evaluates the pharmacokinetics and target engagement of CT-P39 and reference omalizumab in patients with CSU who had physician-reported asthma at baseline.^[1]-[3]

The presentations come after last month's U.S. launch of OMLYCLO, the first and only FDA-approved interchangeable biosimilar to XOLAIR^® (omalizumab).

"Chronic spontaneous urticaria can affect far more than the skin, and allergists increasingly recognize that CSU can have systemic features and frequent comorbidities. The impact on quality of life can be substantial, with approximately 40% of patients with CSU scoring greater than 10 on the Dermatology Life Quality Index, ^[4]" said Dr. Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion USA. "The analyses being presented at ACAAI add to the body of evidence supporting OMLYCLO and reflect Celltrion's commitment to advancing clinically meaningful research for the allergy and immunology community."

Presentation Details
All three analyses will be presented during ePoster Meet the Author sessions at the Phoenix Convention Center.
Disease Activity and Quality of Life During Omalizumab Treatment
Date: Saturday, Nov. 14, from 12:30-12:45 p.m. MT
Abstract Title: "Association Between Disease Activity and Quality of Life During Omalizumab Treatment in Chronic Spontaneous Urticaria"
Session: ePoster – Meet the Author
ePoster: R100 (Monitor 15)

This post hoc analysis of the Phase 3 study (NCT04426890) included patients with CSU who received omalizumab 300 mg every four weeks for 24 weeks, followed by a 16-week off-treatment period. Disease activity, assessed by the Weekly Urticaria Activity Score (UAS7), and QoL, assessed by the Dermatology Life Quality Index (DLQI), were each grouped into five previously established categories to track how patients moved between categories over time.^[1]

At baseline, the largest proportion of patients (36.7%) had severe disease and reported a very large effect of CSU on their QoL. Changes in disease control and QoL were observed at Weeks 12, 24 and 40:^[1]

• Week 12: 43.9% of patients were in the well-controlled or complete response categories, while 72.5% reported no or small effect of CSU on QoL
• Week 24 (end of treatment): 44.4% of patients achieved a complete response with no effect of CSU on QoL
• Week 40 (16 weeks off treatment): 41.7% of patients remained in the well-controlled or complete response categories with no or small effect on QoL

The findings indicate that QoL improvements occurred earlier than improvements in disease activity, with Week 40 results suggesting persistent treatment effects up to 16 weeks after omalizumab was stopped.^[1]

Efficacy by Baseline Itch Severity
Date: Sunday, Nov. 15, from 11:30-11:45 a.m. MT
Abstract Title: "Efficacy of Omalizumab in Patients with Chronic Spontaneous Urticaria According to Baseline Itch Severity Category"
Session: ePoster – Meet the Author
ePoster: R114 (Monitor 14)

This post hoc analysis grouped 409 patients from the Phase 3 study who received CT-P39 or reference omalizumab 300 mg every four weeks by baseline Weekly Itch Severity Score (ISS7): ISS7 ≥13 (n=331) or ISS7 <13 (n=78). Outcomes were analyzed descriptively using UAS7 and the Chronic Urticaria Quality of Life Questionnaire (CU-Q₂oL) at Weeks 0, 12, 24 and 40.^[2]

Reductions in UAS7 and CU-Q₂oL scores were observed at all time points regardless of baseline itch severity. At Week 24, mean reductions in UAS7 were comparable between CT-P39 and reference omalizumab within each itch severity group:^[2]

• ISS7 ≥13: –24.8 with CT-P39 vs. –26.3 with reference omalizumab
• ISS7 <13: –15.7 with CT-P39 vs. –16.0 with reference omalizumab

The findings indicate improvements in disease activity and QoL regardless of baseline itch severity, with comparable efficacy indicated between CT-P39 and reference omalizumab. ^[2]

Pharmacokinetics in Patients with CSU and Comorbid Asthma
Date: Sunday, Nov. 15, from 12:45-1:00 p.m. MT
Abstract Title: "Pharmacokinetics of CT-P39 and Reference Omalizumab in Patients with Chronic Spontaneous Urticaria with Comorbid Asthma"
Session: ePoster – Meet the Author
ePoster: R113 (Monitor 13)

CT-P39 was approved based on a Phase 3 study in CSU, with approval in allergic asthma extrapolated based on the shared mechanism of action. This post hoc analysis evaluated pharmacokinetics and target engagement in 41 patients from the Phase 3 study who had physician-reported asthma at baseline and received CT-P39 or reference omalizumab (150 mg or 300 mg) every four weeks.^[3]

At Week 12, mean serum omalizumab concentrations and free immunoglobulin E (IgE) levels were similar between CT-P39 and reference omalizumab at each dose:^[3]

• 300 mg: serum omalizumab concentrations of 26.9 vs. 21.5 µg/mL and free IgE levels of 4.2 vs. 2.7 ng/mL with CT-P39 and reference omalizumab, respectively
• 150 mg: serum omalizumab concentrations of 15.2 vs. 13.1 µg/mL and free IgE levels of 6.1 vs. 2.9 ng/mL with CT-P39 and reference omalizumab, respectively

The findings indicate that CT-P39 demonstrated comparable pharmacokinetics and similar target engagement to reference omalizumab in patients with CSU and comorbid asthma.^[3]

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],[2] 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 oncology, rheumatology, gastroenterology, dermatology, ophthalmology, allergy and bone health. 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 the U.S. subsidiary of Celltrion, Inc., a global biopharmaceutical company that pioneered the world's first monoclonal antibody biosimilar. Established in 2018 and headquartered in Jersey City, New Jersey, Celltrion USA is committed to expanding access to high-quality biologics for U.S. patients. Its portfolio of FDA-approved biosimilars and novel biologics spans oncology, rheumatology, gastroenterology, dermatology, ophthalmology, allergy and bone health. Celltrion USA leverages Celltrion's fully integrated capabilities, from research and development through manufacturing and commercialization, and its U.S. manufacturing facility in Branchburg, New Jersey, strengthens a reliable supply of medicines for U.S. patients. For more information, visit www.celltrionusa.com and follow Celltrion USA on LinkedIn.

FORWARD-LOOKING STATEMENT 

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Trademarks

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

XOLAIR^® is a registered trademark of Novartis AG.

For further information please contact:
Carly Scaduto,
[email protected]
+1-202-591-4000

SOURCE Celltrion USA