Celltrion announced on the 1st that it has submitted a marketing authorization application for CT-P55 to Health Canada. This filing marks the first step in the global approval process for CT-P55. Cosentyx recorded global sales of approximately KRW 10 trillion last year. Starting with Canada, Celltrion plans to pursue entry into major markets including North America and Europe.

CT-P55 is a biosimilar of Cosentyx, an autoimmune disease treatment developed by Novartis. Its active ingredient is secukinumab, a therapy that works by inhibiting interleukin-17A, which is involved in inflammatory responses. Celltrion has applied for approval in Canada for all indications held by the reference product, including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and juvenile idiopathic arthritis.

This application is based on the results of a clinical trial conducted in 172 healthy subjects. Celltrion stated that the trial demonstrated pharmacokinetic equivalence between CT-P55 and the reference product, and confirmed similarity in terms of safety and immunogenicity.

Beginning with the Canadian authorization process, Celltrion plans to proceed with marketing authorization applications in other key countries, including the United States, Europe, and Korea. The company is focusing on the fact that Canada is a market with policies to expand biosimilar adoption and a relatively favorable regulatory environment. Through Canadian approval, the company aims to establish a foothold for entry into the North American market.

The market size is also significant. Last year, global sales of Cosentyx, the reference product, amounted to about USD 6.668 billion (approximately KRW 10 trillion). As Cosentyx is a key therapy used in chronic autoimmune disease areas such as psoriasis and arthritis, CT-P55 is seen as having potential for market entry after commercialization by leveraging price competitiveness and improved prescription accessibility.

Once CT-P55 is commercialized, Celltrion’s portfolio of autoimmune disease treatments will further expand. Celltrion currently offers TNF-α inhibitors and interleukin inhibitor products through Remsima, Remsima SC, Zymfentra (U.S. product name), Yuflyma, Steqima, and Abtozma.

A Celltrion official said, “Based on the accumulated experience in biosimilar development and marketing authorization, the company plans to proceed with the CT-P55 approval process without setbacks,” adding, “Starting with Canada, we will expand approvals to major global markets such as the United States and Europe, strengthen our autoimmune disease treatment portfolio, and translate this into sales growth.”

Celltrion has set a target of expanding its biosimilar portfolio from the current 11 products to 18 by 2030. In the autoimmune disease treatment area, it is developing CT-P53, an Ocrevus biosimilar, and CT-P52, a Taltz biosimilar. In oncology, it is developing CT-P51, a Keytruda biosimilar, and CT-P44, a Darzalex biosimilar.

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