Celltrion's urticaria biosim proven safe and effective in Phase 1 trial

South Korea’s Celltrion on Friday said that the Phase 1 clinical trial of CT-P39, a biosim of Xolair, for the treatment of allergic asthma and chronic urticaria, has demonstrated bioequivalence and safety, raising high expectations in the ongoing global Phase 3 clinical trials.

CT-P39 was confirmed to have pharmacokinetic equivalence with the original drug in the trial involving 176 healthy patients ages between of 18-55 years.

The results were presented at the Urticaria Centers of Reference and Excellence (UCARE) 2021 conference. UCARE is an organization to promote global exchanges among member institutions in urticaria treatment, research, and education. This year's conference is being held both online and offline in Hiroshima, Japan on Dec. 9-11.

CT-P39 references Xolair, an antibody biologic developed by Genentech and Novartis, is a blockbuster product with global sales of about $3.3 billion last year.

CT-P39 is currently being evaluated in global Phase 3 trials with a target enrollment of 600 patients with chronic idiopathic urticaria. Trial completion is expected by the first half of 2023.

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