Celltrion recently announced on December 27 that it has completed the filing of a Marketing Authorization Application with Health Canada for CT-P39, a biosimilar to XOLAIR (omalizumab).
Celltrion demonstrated efficacy and equivalence to the originator in a global Phase 3 clinical trial of CT-P39, which included a total of 619 patients with Chronic Spontaneous Urticaria in six European countries, and confirmed similarities in safety.
Based on these results, Celltrion has completed a license application to Health Canada for the full label approved for the original drug in allergic asthma, chronic rhinosinusitis, and chronic urticaria.
Celltrion plans to file for authorization in Europe and Korea in the first half of this year, and plans to file for authorization in other key countries, including the United States.
Zolair, the original CT-P39 drug, is an antibody biologic 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 $5 trillion in 2022, the substance patent has already expired and the formulation patent is scheduled to expire in March 2024 in Europe and November 2025 in the United States.
Canada has had a pro-biosimilar policy since 2019. Recently, the province of Prince Edward Island announced its intention to become the eleventh of 13 Canadian provinces to implement a biosimilar switching policy, indicating that Canada is actively creating an enabling environment to encourage biosimilar prescribing, and the market is expected to continue to expand.
"In recent years, policies favoring biosimilars have been expanding in major countries around the world, including Canada, the U.S., and Europe," said an official from Celltrion. "We will do our best to supply high-quality biopharmaceuticals and improve patient access to treatment by expanding our portfolio to a variety of conditions, including autoimmune diseases and anticancer drugs, as well as treatments for allergic diseases."
