Celltrion Applies for Canadian Approval of Zolair Biosimilar 'CT-P39'

Celltrion recently announced on the 27th that it has completed the marketing authorization application for 'CT-P39', a biosimilar of 'Xolair' (active ingredient omalizumab), with Health Canada.

Incheon Songdo Celltrion Plant 2 Overview. / Incheon - Photo by Hyunmin Kim kimhyun81@

This application covers the full label indications approved for the original drug, including allergic asthma, chronic rhinosinusitis, and chronic urticaria. Celltrion had previously applied for CT-P39 approval in Europe and South Korea in April and June respectively, and plans to sequentially apply for approval in major countries such as the United States following Canada.

Celltrion explained that it demonstrated efficacy equivalence and safety similarity of CT-P39 compared to the original drug in a study involving 619 patients with chronic spontaneous urticaria in six European countries including Poland and Bulgaria.

The original drug of ‘CT-P39’, Xolair, is an antibody biopharmaceutical developed by Genentech in the United States and Novartis in Switzerland. It is used to treat allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic spontaneous urticaria. It recorded global sales of $3.89 billion (approximately 5 trillion KRW) last year, making it a blockbuster product. The substance patent has already expired, and the formulation patent is set to expire in March next year in Europe and November 2025 in the United States.

Canada is a representative country adopting biosimilar-friendly policies. Recently, Prince Edward Island became the 11th province out of 13 in Canada to announce the implementation of a biosimilar switching policy, creating an actively encouraging environment for biosimilar prescriptions within Canada.

A Celltrion official stated, “Biosimilar-friendly policies are expanding globally, especially in major countries such as Canada, the United States, and Europe. Following our strengths in autoimmune diseases and oncology drugs, Celltrion will expand its portfolio to various diseases including allergy treatments, striving to supply high-quality biopharmaceuticals and improve patient access to treatment.”

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