Celltrion said Wednesday that it has completed the submission of its marketing authorization 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 (CSU) in six EU countries, demonstrating the efficacy and equivalence of CT-P39 to the originator drug and confirmed similarity in safety.
Based on these results, Celltrion completed a license application to Health Canada for all indications for which the original drug was licensed, including allergic asthma, chronic rhinosinusitis, and chronic urticaria.
Xolair was developed by Genentech and Novartis for the treatment of allergic asthma, chronic rhinosinusitis with nasal polyposis, and chronic idiopathic urticaria.
A blockbuster product with global sales of approximately $3.9 billion in 2022, the substance patent has already expired and the formulation patent is set to expire in March 2024 in Europe and November 2025 in the U.S.
Canada has been adopting pro-biosimilar policies since 2019. With the recent announcement that Prince Edward Island will become the 11th of 13 Canadian provinces to implement a biosimilar switching policy, the environment is conducive to encouraging biosimilar prescribing in Canada, and the market is expected to continue to expand.
"In recent years, we have seen an expansion of pro-biosimilar policies in key countries around the world, including Canada, the U.S. and Europe," a Celltrion official said. "Celltrion will continue to expand its portfolio from autoimmune diseases and anticancer drugs, where it has shown strength, to various diseases such as allergic diseases, and will do its best to provide high-quality biologics and increase patient access to treatment."
Meanwhile, Celltrion is accelerating the development of follow-on products, with the goal of having 11 biosimilars by early 2025 and a total of 22 by 2030, in addition to the six already commercialized.
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