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# Celltrion BLA for Interchangeable Xolair Biosimilar
- URL: https://www.fdaweb.com/celltrion-bla-for-interchangeable-xolair-biosimilar/
- Published: 2025-03-07T12:00:00.000Z
- Updated: 2026-09-14T14:54:46.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5158786

FDA has approved a Celltrion BLA for Omlyclo, the first interchangeable biosimilar to Genentech’s Xolair (omalizumab). The biosimilar is approved for treating the following conditions:

- Moderate to severe persistent asthma in patients greater than six years of age whose asthma symptoms are not well controlled with inhaled corticosteroids.
- Chronic rhinosinusitis with nasal polyps in patients greater than 18 years of age.
- Food allergies in people one year of age and older to reduce allergic reactions.
- Chronic spontaneous urticaria in people 12 years of age and older.

An [FDA release](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?ApplNo=761399&event=overview.process&utm%5Fmedium=email&utm%5Fsource=govdelivery) says Omlyclo works by “binding to immunoglobulin E (IgE), the antibody type that triggers allergic reactions, and blocks IgE from binding to its receptors. Omlyclo is administered subcutaneously for all indications, but it has different dosing instructions for each indication. Side effects from Omlyclo include injection site reactions, fever, headache, dizziness, and arthralgia.”

Additionally, the agency says Omlyclo has a Boxed Warning for anaphylaxis, which can be life threatening, based on pre-marketing and post-marketing reports.