Celltrion Initiates Global Phase 3 Clinical Trials for Asthma and Urticaria Biosimilars

Approval of Clinical Trial Plan... Conducted at 65 Clinical Trial Sites in 7 Countries Including South Korea

[Asia Economy Reporter Seo So-jung] Celltrion announced on the 8th that it received approval from the Ministry of Food and Drug Safety for the clinical trial application (IND) of ‘CT-P39,’ a biosimilar of ‘Xolair’ (active ingredient omalizumab), a treatment for allergic asthma and chronic urticaria.

Celltrion plans to conduct a Phase 3 clinical trial involving 600 patients with idiopathic urticaria across approximately 65 clinical trial sites in seven countries worldwide, including South Korea. Through comparative clinical trials between CT-P39 and Xolair, Celltrion aims to demonstrate equivalence in terms of efficacy and safety, with the goal of completing the Phase 3 trial within the first half of 2023.

Since July of last year, Celltrion has been conducting a global Phase 1 clinical trial to evaluate safety and pharmacokinetics. The interim results from Phase 1 have secured safety data, and the company has now entered the global Phase 3 trial to conduct confirmatory therapeutic studies for regulatory approval.

Xolair is an antibody biologic marketed by Genentech and Novartis, and it recorded global sales of approximately 3.9 trillion KRW last year, making it a blockbuster product.

A Celltrion official stated, "Celltrion is accelerating global clinical trials for follow-up biosimilars following Remsima, Truxima, and Herzuma," adding, "We will do our best to successfully conduct the global Phase 3 clinical trial of CT-P39 and supply high-quality biologics at reasonable prices to patients worldwide as early as possible."

This content was produced with the assistance of AI translation services.