OMLYCLO is the FIRST and ONLY FDA‑approved biosimilar interchangeable with Xolair, with the same indications, efficacy, safety, and MOA1,2
Manufactured by Celltrion, a global leader in biopharmaceuticals.
FDA, Food and Drug Administration; MOA, mechanism of action.
A biosimilar is an FDA-approved biologic that is highly similar to its reference product, with no clinically meaningful differences in safety, purity, or potency. An interchangeable biosimilar meets additional FDA requirements and may be substituted for the reference product.6,7
OMLYCLO is the FIRST and ONLY FDA-approved biosimilar interchangeable with Xolair1,2
In the phase 3 study, OMLYCLO demonstrated therapeutic equivalence to Xolair for the primary endpoint of change from baseline in ISS7 at week 12.3
*ISS7 is a patient-reported measure of itch severity recorded twice a day. Scores are calculated at the end of every 7 days (range 0-21). Higher scores indicate greater itch severity.1
CI, confidence interval. IgE, immunoglobulin E; ISS7, weekly itch severity score; mITT, modified intent-to-treat population.
OMLYCLO offers identical dosing and administration as Xolair so it can be integrated into your existing treatment protocol.1,5
We can help you empower your patients to navigate their treatment journeys confidently and seamlessly.
References: 1. OMLYCLO Prescribing Information. Celltrion USA, Inc; 2025. 2. US Food and Drug Administration. BLA approval letter 761399 for OMLYCLO. Published March 7, 2025. 3. 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 4. 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 5. Xolair Prescribing Information. Genentech, Inc; 2024. 6. US Food and Drug Administration. Biosimilar Product Regulatory Review and Approval. Accessed March 17, 2026. https://www.fda.gov/files/drugs/published/Biosimilar-Product-Regulatory-Review-and-Approval.pdf 7. US Food and Drug Administration. Biosimilars Info Sheet Level 1. Accessed May 5, 2026. https://www.fda.gov/media/154911/download
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:
OMLYCLO® (omalizumab-igec) injection is an anti-IgE antibody indicated for:
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.
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:
OMLYCLO® (omalizumab-igec) injection is an anti-IgE antibody indicated for:
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.