For US healthcare professionals only

OMLYCLO immunogenicity profile was the same as Xolair® profile1*

OMLYCLO and Xolair ADA profiles were similar at week 24, even in the switch population1

Patients ADA+ at week 242

Treatment Path Percentage
Continued OMLYCLO (n=11/187) 5.9%
Continued Xolair (n=1/96) 1.0%
Switched Xolair → OMLYCLO (n=3/96) 3.1%

  • All patient populations demonstrated low ADA positivity rates and no neutralizing antibodies were observed1

Switching from Xolair to OMLYCLO showed no meaningful impact on immunogenicity.1

*When studied in patients with chronic spontaneous urticaria.

ADA, antidrug antibody; ADA+, antidrug antibody positive.

OMLYCLO safety profile is the same as Xolair1,2*

Chart comparing treatment-emergent adverse events related to the study drug among patients receiving OMLYCLO, Xolair, and patients who switched treatments during treatment periods 1 and 2. Chart comparing treatment-emergent adverse events related to the study drug among patients receiving OMLYCLO, Xolair, and patients who switched treatments during treatment periods 1 and 2.

  • The most common adverse reactions during the overall treatment period reported in patients treated with OMLYCLO were nasopharyngitis (5.4%), COVID-19 (4.9%), headache (3.0%), and injection-site reactions (2.5%)2
  • Serious adverse events were infrequent (<3% during each treatment period), with none reported in more than 1 patient in any group; treatment-related TEAEs leading to discontinuation included myocardial ischemia, peripheral edema, hemorrhoids, and injection-site reaction. One death due to suicide was reported in TP2 and was considered unrelated to treatment1

*When studied in patients with chronic spontaneous urticaria.

TEAE, treatment-emergent adverse event; TESAE, treatment-emergent serious adverse event; TP2, treatment period 2.

OMLYCLO and Xolair demonstrated the same safety profiles1*

TEAEs in ≥2% of patients in any treatment group2

Preferred Term OMLYCLO 300 mg (n=203) OMLYCLO 150→300 mg (n=107) Switched to OMLYCLO 300 mg (n=96) Xolair 300 mg (n=205) Xolair 150→300 mg (n=103) Continued Xolair 300 mg (n=96)
Nasopharyngitis 5.4% 7.5% 2.1% 3.9% 1.9% 6.3%
COVID-19 4.9% 5.6% 4.2% 4.9% 4.9% 6.3%
Headache 3.0% 0 1.0% 2.9% 4.9% 5.2%
ISR 2.5% 1.9% 6.3% 5.9% 2.9% 5.2%
Arthralgia 1.5% 1.9% 3.1% 1.5% 1.9% 0
URI 1.5% 4.7% 1.0% 1.5% 1.9% 2.1%

TEAEs in ≥2% of patients in any treatment group2

TEAEs for patients who started treatment

  • During TP1, similar proportions of patients in the OMLYCLO 300 mg group (25.6%) and the Xolair 300 mg group (26.3%) experienced TEAEs of any intensity1
  • During TP2, the incidence of TEAEs was also similar among patients continuing OMLYCLO 300 mg (25.1%), continuing Xolair 300 mg (26.0%), and switching to OMLYCLO 300 mg (26.0%)2

*When studied in patients with chronic spontaneous urticaria.

COVID-19, coronavirus-19; ISR, injection site reaction; TEAE, treatment-emergent adverse event; TP1, treatment period 1; TP2, treatment period 2; URI, upper respiratory infection.

OMLYCLO demonstrated the same safety profile as Xolair—shown at 40 weeks3*

Overview of TEAEs up to week 403

Event Follow-up period (week 24–40) Overall study period
Continued OMLYCLO 300 mg (n=203) Continued Xolair 300 mg (n=205) Switched to OMLYCLO 300 mg (n=96) Continued OMLYCLO 300 mg (n=203) Continued Xolair 300 mg (n=96) Switched to OMLYCLO 300 mg (n=96)
≥1 TEAE 18.2% 19.0% 19.8% 43.8% 49.0% 50.0%
Related 0.5% 0% 0% 8.4% 9.4% 12.5%

Overview of TEAEs up to week 403

Overview of TEAEs up to week 40 for patients who continued treatment

*When studied in patients with chronic spontaneous urticaria.

Like Xolair, there are no known drug interactions with OMLYCLO.4,5

Explore Dosing Information

References: 1. Saini SS, Maurer M, Dytyatkovska Y, et al. CT-P39 compared with reference omalizumab in chronic spontaneous urticaria: results from a double-blind, randomized, active-controlled, phase 3 study. Allergy. 2025;80(7):2167–2177. doi:10.1111/all.16446 2. Saini SS, Maurer M, Dytyatkovska Y, et al. Supplementary material to: CT-P39 compared with reference omalizumab in chronic spontaneous urticaria: results from a double-blind, randomized, active-controlled, phase 3 study. Allergy. 2025;80(7):2167-2177. doi:10.1111/all.16446 3. Grattan C, Dytyatkovska Y, Springer M, et al. Efficacy and safety of CT-P39, an omalizumab biosimilar, in chronic spontaneous urticaria: results from a 16-week follow-up study. Clin Transl Allergy. 2025;15(6):e70069. doi:10.1002/clt2.70069 4. OMLYCLO Prescribing Information. Celltrion USA, Inc.; 2025. 5. Xolair Prescribing Information. Genentech, Inc.; 2024.

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. Healthcare 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. Life-threatening anaphylaxis has occurred after omalizumab products, with signs/symptoms including bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue; it can occur as early as the first dose, beyond 1 year after starting, and has been reported up to 4 days after administration. Initiate OMLYCLO in a healthcare setting equipped to manage anaphylaxis and observe patients for an appropriate period after dosing; educate patients on signs/symptoms and the need for immediate medical care. Risk is increased in patients with a history of anaphylaxis to foods, medications, or other causes. After therapy is safely established, self-administration OMLYCLO prefilled syringe may be appropriate for selected patients/caregivers based on risk mitigation (including no prior history of anaphylaxis, at least 3 supervised doses without hypersensitivity, ability to recognize and appropriately treat anaphylaxis, and ability to perform SC injections correctly). Discontinue OMLYCLO in patients who experience a severe hypersensitivity reaction.

Malignancy. Malignant neoplasms have been observed in clinical studies; the impact of longer exposure and use in patients at higher baseline risk is not known, and limitations of longer-term observational data preclude definitively ruling out a malignancy risk with omalizumab products.

Acute Asthma Symptoms and Deteriorating Disease. Omalizumab products have not been shown to relieve acute asthma exacerbations; do not use OMLYCLO to treat acute bronchospasm or status asthmaticus. Advise patients to seek medical care if asthma remains uncontrolled or worsens after starting OMLYCLO.

Corticosteroid Reduction. Do not abruptly discontinue systemic or inhaled corticosteroids when starting OMLYCLO for asthma or CRSwNP; taper gradually under physician supervision. In CSU patients, use of omalizumab products in combination with corticosteroids has not been evaluated.

Eosinophilic Conditions. In rare cases, patients with asthma on omalizumab products have developed serious systemic eosinophilia, sometimes with vasculitis consistent with Churg-Strauss syndrome, often in the setting of oral corticosteroid reduction. Be alert for eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy; a causal association has not been established.

Fever, Arthralgia, and Rash. In post-approval use, a serum sickness-like constellation (arthritis/arthralgia, rash, fever, lymphadenopathy) has occurred 1 to 5 days after injections and may recur with additional doses; stop OMLYCLO if this constellation develops.

Parasitic (Helminth) Infection. Monitor patients at high risk of geohelminth infection during OMLYCLO therapy; available data are insufficient to define the duration of monitoring needed after stopping treatment. A clinical trial in a high-risk setting observed more infections with omalizumab than placebo; response to appropriate anti-geohelminth treatment was not different between groups.

Laboratory Tests. Total serum IgE increases after dosing and may remain elevated for up to 1 year after discontinuation due to drug-IgE complexes; do not use total IgE levels obtained less than 1 year after discontinuation to reassess dosing regimen for asthma, CRSwNP, or IgE-mediated food allergy because these levels may not reflect steady-state free IgE levels.

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.

INDICATIONS

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 ≥1 year of 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; and other forms of urticaria.

Please see the full Prescribing Information for complete details. To report suspected adverse reactions, contact CELLTRION USA, INC. at 1‑800‑560‑9414 or FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.

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. Healthcare 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. Life-threatening anaphylaxis has occurred after omalizumab products, with signs/symptoms including bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue; it can occur as early as the first dose, beyond 1 year after starting, and has been reported up to 4 days after administration. Initiate OMLYCLO in a healthcare setting equipped to manage anaphylaxis and observe patients for an appropriate period after dosing; educate patients on signs/symptoms and the need for immediate medical care. Risk is increased in patients with a history of anaphylaxis to foods, medications, or other causes. After therapy is safely established, self-administration OMLYCLO prefilled syringe may be appropriate for selected patients/caregivers based on risk mitigation (including no prior history of anaphylaxis, at least 3 supervised doses without hypersensitivity, ability to recognize and appropriately treat anaphylaxis, and ability to perform SC injections correctly). Discontinue OMLYCLO in patients who experience a severe hypersensitivity reaction.

Malignancy. Malignant neoplasms have been observed in clinical studies; the impact of longer exposure and use in patients at higher baseline risk is not known, and limitations of longer-term observational data preclude definitively ruling out a malignancy risk with omalizumab products.

Acute Asthma Symptoms and Deteriorating Disease. Omalizumab products have not been shown to relieve acute asthma exacerbations; do not use OMLYCLO to treat acute bronchospasm or status asthmaticus. Advise patients to seek medical care if asthma remains uncontrolled or worsens after starting OMLYCLO.

Corticosteroid Reduction. Do not abruptly discontinue systemic or inhaled corticosteroids when starting OMLYCLO for asthma or CRSwNP; taper gradually under physician supervision. In CSU patients, use of omalizumab products in combination with corticosteroids has not been evaluated.

Eosinophilic Conditions. In rare cases, patients with asthma on omalizumab products have developed serious systemic eosinophilia, sometimes with vasculitis consistent with Churg-Strauss syndrome, often in the setting of oral corticosteroid reduction. Be alert for eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy; a causal association has not been established.

Fever, Arthralgia, and Rash. In post-approval use, a serum sickness-like constellation (arthritis/arthralgia, rash, fever, lymphadenopathy) has occurred 1 to 5 days after injections and may recur with additional doses; stop OMLYCLO if this constellation develops.

Parasitic (Helminth) Infection. Monitor patients at high risk of geohelminth infection during OMLYCLO therapy; available data are insufficient to define the duration of monitoring needed after stopping treatment. A clinical trial in a high-risk setting observed more infections with omalizumab than placebo; response to appropriate anti-geohelminth treatment was not different between groups.

Laboratory Tests. Total serum IgE increases after dosing and may remain elevated for up to 1 year after discontinuation due to drug-IgE complexes; do not use total IgE levels obtained less than 1 year after discontinuation to reassess dosing regimen for asthma, CRSwNP, or IgE-mediated food allergy because these levels may not reflect steady-state free IgE levels.

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.

INDICATIONS

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 ≥1 year of 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; and other forms of urticaria.

Please see the full Prescribing Information for complete details. To report suspected adverse reactions, contact CELLTRION USA, INC. at 1‑800‑560‑9414 or FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.