Omlyclo FDA Approval History
Last updated by Judith Stewart, BPharm on March 8, 2025.
FDA Approved: Yes (First approved March 7, 2025)
Brand name: Omlyclo
Generic name: omalizumab-igec
Dosage form: Injection
Company: Celltrion USA
Treatment for: Asthma, Maintenance, Chronic Rhinosinusitis With Nasal Polyps, Food Allergies, Urticaria
Omlyclo (omalizumab-igec) is an anti-IgE antibody interchangeable biosimilar to Xolair for the treatment of asthma, chronic rhinosinusitis with nasal polyps, IgE-mediated food allergy, and urticaria.
- Omlyclo is indicated for:
- moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older 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 and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment.
- IgE-mediated food allergy in adult and pediatric patients aged 1 year and older 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 and older who remain symptomatic despite H1 antihistamine treatment. - Omlyclo (omalizumab-igec) is biosimilar to Xolair (omalizumab) and has an interchangeability designation.
- FDA approval for Omlyclo was supported by positive phase III data that demonstrated a comparable efficacy and safety profile with the reference product Xolair.
- Omlyclo is administered by subcutaneous injection every 2 or 4 weeks (every 4 weeks for chronic spontaneous urticaria).
- Omlyclo carries a Boxed Warning for anaphylaxis. Omlyclo therapy must be initiated in a healthcare setting and patients must be closely observed for an appropriate period of time after administration. Warnings and precautions associated with Omlyclo include anaphylaxis and malignancies. Omlyclo must not be used for the treatment of acute asthma symptoms.
- Common adverse reactions:
- Asthma in adult and adolescent patients ≥12 years of age (≥ 1% of patients) include arthralgia, pain (general), leg pain, fatigue, dizziness, fracture, arm pain, pruritus, dermatitis, and earache.
- Asthma in pediatric patients 6 to <12 years of age (≥ 3% of patients) include nasopharyngitis, headache, pyrexia, upper abdominal pain, pharyngitis streptococcal, otitis media, viral gastroenteritis, arthropod bites, and epistaxis.
- Chronic Rhinosinusitis with Nasal Polyps (≥ 3% of patients) include headache, injection site reaction, arthralgia, upper abdominal pain, and dizziness.
- IgE-Mediated Food Allergy (≥3% of patients) include injection site reactions and pyrexia.
- Chronic Spontaneous Urticaria (≥2% of patients) include nausea, nasopharyngitis, sinusitis, upper respiratory tract infection, viral upper respiratory tract infection, arthralgia, headache, and cough.
Development timeline for Omlyclo
Further information
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