FDA approves omalizumab biosimilar Omlyclo
Key takeaways:
- Omlyclo is the first interchangeable biosimilar to omalizumab (Xolair; Genentech, Novartis).
- Omlyclo was approved to treat the same conditions as Xolair.
The FDA approved Celltrion’s omalizumab biosimilar, Omlyclo, for the treatment of multiple conditions including asthma and food allergy, according to an agency press release.
Omlyclo (omalizumab-igec) is the first interchangeable biosimilar to omalizumab (Xolair; Genentech, Novartis), according to the FDA.
Omlyclo was approved to treat the same conditions as Xolar, including moderate to severe persistent asthma in people aged 6 years and older, food allergy in people aged 1 year and older, chronic spontaneous urticaria in people aged 12 years and older, and chronic rhinosinusitis with nasal polyps in adults aged 18 and older.
Almost 1 year ago, Celltrion submitted a biologics license application based on phase 3 data that compared efficacy, safety and pharmacokinetics of Omlyclo with that of Xolair.
At the American Academy of Allergy, Ashma & Immunology/World Allergy Organization Joint Congress last week, researchers reported patients with multiple food allergies were able to introduce allergens into their diets and were more like to achieve tolerance compared with oral immunotherapy.
Adverse events associated with Omlyclo include injection site reactions, fever, headache, dizziness and arthralgia. The biologic also includes a boxed warning for anaphylaxis, which could occur up to days after a dose.
The press release noted that Omlyclo should not be used for emergency treatment of allergic reactions, acute bronchospasm, status asthmaticus or other forms of urticaria.
“We are excited about any developments that may help to lower medication costs and potentially bring important treatments to a greater number of patients,” Robert A. Wood, MD, director of the Eudowood Division of Allergy, Immunology and Rheumatology at Johns Hopkins Children's Center and lead author on the OUtMATCH study of the use of omalizumab in food allergy, told Healio.
References:
- Celltrion USA completes submission of biologics license application to US FDA for CT-P39, an interchangeable biosimilar candidate of Xolair (omalizumab). https://www.prnewswire.com/news-releases/celltrion-usa-completes-submission-of-biologics-license-application-bla-to-us-fda-for-ct-p39-an-interchangeable-biosimilar-candidate-of-xolair-omalizumab-302084902.html. Published March 10, 2024. Accessed March 7, 2025.
- FDA approves first interchangeable biosimilar to Xolair. Published March 7, 2025. Accessed March 7, 2025.