Celltrion USA Submits Biologics License Application for CT-P39, a Biosimilar to Xolair


The BLA includes all indications for Xolair, including asthma, chronic rhinosinusitis with nasal polyps, immunoglobulin E-mediated food allergy, and chronic spontaneous urticaria.

Celltrion USA announced the FDA submission of a biologics license application (BLA) for CT-P39, an interchangeable biosimilar candidate to omalizumab (Xolair; Genentech, Roche), according to a press release. The BLA includes all indications for Xolair, including asthma, chronic rhinosinusitis with nasal polyps, immunoglobulin E (IgE)-mediated food allergy, and chronic spontaneous urticaria (CSU).1

Laboratory test tubes and solution with stethoscope background. | Image Credit: Shutter2U - stock.adobe.com

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"We are pleased with the rapid progress made in the development of CT-P39, and we look forward to expanding our portfolio beyond immunology and oncology," Thomas Nusbickel, chief commercial officer at Celltrion USA, said in the press release. "We will continue to build upon our strong track record of developing and manufacturing high-quality biosimilars to help improve the lives of patients."1

The BLA submission included data from a phase 3 clinical trial that evaluated the efficacy, safety, and pharmacokinetics of the biosimilar to the reference product for patients with CSU up to 40 weeks, the press release said. The primary results of the clinical trial were presented at the American College of Allergy, Asthma, and Immunology conference in Anaheim, California.1

In February 2024, the FDA approved omalizumab for the reduction of allergic reactions, including anaphylaxis, that may occur after accidental exposure to 1 or more foods in individuals aged 1 year and older with IgE-mediate food allergy. This marks the first and only medication approved by the FDA that reduces reactions in patients with food allergies, according to an article in Pharmacy Times.2

The FDA approval was based off of positive data from the OUtMATCH trial (NCT03881696), a multicenter, randomized, placebo-controlled phase 3 trial intended to evaluate the safety and efficacy of the drug in individuals who were allergic to peanuts and at least 2 other food allergens, such as milk, egg, wheat, and nuts. Treatment was randomly assigned so that patients received either the placebo or omalizumab injections either every 2 weeks or every 4 weeks for approximately 16 to 20 weeks.2

Key Takeaways

  1. Celltrion submitted a BLA to FDA for CT-P39, a biosimilar to Xolair (omalizumab) used for asthma, allergies, and chronic hives.
  2. The biosimilar showed similar efficacy and safety to the reference drug in treating chronic spontaneous urticaria (CSU) in a clinical trial.
  3. Omalizumab recently got FDA approval to reduce allergic reactions, including anaphylaxis, from accidental food exposure in individuals aged 1 and older with IgE-mediated food allergies. This is the first medication approved for this purpose.

The study findings were published in the New England Journal of Medicine following the late-breaking symposium at the AAAAI Annual Meeting. The investigators found that there was a higher proportion of individuals taking omalizumab who were able to consume at least 600 mg of peanut protein at 67% compared to 7% for the placebo, and at least 1000 mg of milk, egg, and cashew protein without a moderate to severe allergic reaction at 66%, 67%, and 41% compared with 10%, 0%, and 3%, respectively. For walnuts, approximately 64% of those receiving omalizumab could consume the protein compared to 13% of individuals with the placebo while those consuming hazelnut and wheat could at 65% and 75% compared to 14% and 13%, respectively, according to the study results.3

Omalizumab is not approved for the emergency treatment of any allergic reaction, according to the article.3

  1. Celltrion USA completes submission of Biologics License Application (BLA) to US FDA for CT-P39, an interchangeable biosimilar candidate of Xolair (omalizumab). News release. Celltrion USA. March 10, 2024. Accessed March 15, 2024. https://www.celltrion.com/en-us/company/media-center/press-release/3125
  2. McGovern G. FDA Approves Omalizumab to Reduce Food-Based Allergic Reactions in Adult and Pediatric Patients. Pharmacy Times. February 16, 2024. Accessed March 15, 2024. https://www.pharmacytimes.com/view/fda-approves-omalizumab-to-reduce-food-based-allergic-reactions-in-adult-and-pediatric-patients
  3. Gallagher A. Data From OUtMATCH Study Show Benefits of Xolair for Common Food Allergies. Pharmacy Times. February 27, 2024. Accessed March 15, 2024. https://www.pharmacytimes.com/view/data-from-outmatch-study-show-benefits-of-xolair-for-common-food-allergies
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