Categories
Change Password!
Reset Password!
The FDA has authorized omalizumab-igec as the first interchangeable biosimilar to omalizumab for treating asthma, urticaria, chronic rhinosinusitis with nasal polyps, and food allergy.
On March 3, 2025, the United States Food and Drug Administration (FDA) approved omalizumab-igec as the first interchangeable biosimilar to omalizumab, offering a new treatment option for patients with moderate-to-severe allergic and inflammatory conditions. The newly approved biosimilar is authorized for subcutaneous use across the following indications:
Limitations of Use
The biosimilar is not authorized for acute asthma attacks, emergency care of anaphylaxis, or other forms of urticaria.
How It Works
This omalizumab biosimilar binds to immunoglobulin E (IgE), blocking its interaction with receptors on immune cells and thereby reducing allergic inflammation.
Administration and Safety
The treatment is given via subcutaneous injection, with dosing individualized by condition. Common adverse effects encompass fever, injection site reactions, joint pain, dizziness, and headache.
A boxed warning highlights the risk of anaphylaxis, which can occur after any dose — even the first — and may be delayed. Therefore, treatment must be initiated only in healthcare settings equipped to tackle severe allergic reactions.
Regulatory Impact
This marks the first FDA-approved interchangeable biosimilar to omalizumab, offering a new option for patients and healthcare systems, with the potential to improve access while maintaining therapeutic standards.
U.S. Food and Drug Administration
FDA Approves First Interchangeable Biosimilar to Xolair
Comments (0)