Celltrion Submits Application for Interchangeable Xolair Biosimilar

Celltrion USA has submitted a biologics license application (BLA) for CT-P39, an interchangeable biosimilar that references Genentech’s Xolair (omalizumab).

The BLA submission includes results from a global phase 3 clinical trial designed to evaluate the efficacy, safety, and pharmacokinetics of CT-P39 compared with the reference product Xolair in patients with chronic spontaneous urticaria (CSU) up to Week 40.

In November 2023, Celltrion presented the primary results of its 12-week clinical trial during the American College of Allergy, Asthma and Immunology (ACAAI) conference.

The application includes the same indication as Xolair, including asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), chronic spontaneous urticaria and its recently approved indication IgE-mediated food allergy.

Last month, Xolair was approved to reduce allergic reactions, including anaphylaxis, that may occur in people with food allergies. Immunoglobulin E (IgE)-mediated food allergies are the most common type and are typically characterized by the rapid onset of symptoms following exposure to certain food allergens.

In Genetech’s study of Xolair, 67% of the 118 of the participants in the OUtMATCH trial who were treated with Xolair injections for between 16 and 20 weeks met the trial’s primary endpoint, which was consumption of 600 milligrams (mg) of peanut protein (about the amount in three to four peanuts) without moderate or severe allergic reaction (or combination of mild reactions). The reactions included hives, swelling, itching, throat tightness and abdominal pain, nausea or vomiting. Results were published in the New England Journal of Medicine (NEJM).