Posted by Michael Wonder on 28 Dec 2023
Celltrion seeks approval for Xolair biosimilar in Canada
27 December 2023 - Celltrion said Wednesday that it has completed the submission of its marketing authorisation application for its Xolair (omalizumab) biosimilar, CT-P39, to Health Canada.
The application is based on results from Celltrion's global Phase 3 clinical trial of CT-P39, which enrolled a total of 619 patients with chronic spontaneous urticaria in six EU countries, demonstrating the efficacy and equivalence of CT-P39 to the originator drug and confirmed similarity in safety.
