What is OMLYCLO (omalizumab-igec)?
OMLYCLO (omalizumab-igec) is a biosimilar of the reference monoclonal anti-IgE antibody omalizumab (Xolair), approved by the FDA in March 2025 as the first biosimilar for treating allergic diseases and asthma. 1, 2
Drug Classification and Mechanism
OMLYCLO is a humanized monoclonal IgG1 antibody that binds to immunoglobulin E (IgE), preventing IgE from attaching to mast cells and basophils, thereby reducing allergic and inflammatory responses 1.
Approved Indications
OMLYCLO is approved for all indications where reference omalizumab is used:
- Allergic asthma (moderate to severe, IgE-mediated)
- Chronic rhinosinusitis with nasal polyps
- Chronic spontaneous urticaria (CSU) unresponsive to H1-antihistamines
- IgE-mediated food allergy (in the USA) 1, 2
Biosimilar Equivalence
CT-P39 (OMLYCLO's designation) has demonstrated:
- Similar physicochemical and pharmacodynamic properties to reference omalizumab
- Pharmacokinetic equivalence in healthy volunteers
- Clinical efficacy equivalent to reference omalizumab in CSU patients
- Similar tolerability, safety, and immunogenicity profiles
- No impact on efficacy or safety when switching from reference omalizumab 1
Clinical Significance
The approval of OMLYCLO represents a major advancement in improving accessibility and affordability of biologic therapy for patients with severe allergic conditions and asthma. 2 This biosimilar provides a cost-effective alternative while maintaining the same quality and efficacy standards as the reference product.
Important Safety Consideration
Like reference omalizumab, OMLYCLO carries a risk of anaphylaxis (approximately 0.2% of patients). Patients should:
- Be observed for 2 hours after the first 3 injections, then 30 minutes for subsequent doses
- Carry an epinephrine autoinjector at all times
- Receive proper education about anaphylaxis signs and symptoms 3