Celltrion (068270.KS) has launched its push into the North American market by initiating the Canadian approval process for its biosimilar of Cosentyx, an autoimmune disease treatment.
Celltrion announced Wednesday that it has filed for marketing approval with Health Canada for CT-P55, a biosimilar of Cosentyx (active ingredient: secukinumab). CT-P55 is an autoimmune disease treatment in the interleukin (IL)-17A inhibitor class.
In Canada, Celltrion has applied for approval covering all indications held by the original drug, including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and juvenile idiopathic arthritis. The filing is based on clinical trial results conducted with 172 healthy subjects. In the trial, CT-P55 demonstrated pharmacokinetic equivalence compared to the original drug and confirmed similarity in terms of safety and immunogenicity.
Starting with Canadian approval, Celltrion plans to sequentially pursue approval procedures in major countries including the United States, Europe, and South Korea. Canada is regarded as a leading biosimilar-friendly market that has pursued policies to expand biosimilar adoption. Celltrion's strategy is to use Canada as a bridgehead for entering the North American market and accelerate global commercialization.
Once approval is completed, Celltrion's autoimmune disease treatment portfolio will further expand. Celltrion has built a lineup of autoimmune disease treatments spanning tumor necrosis factor alpha (TNF-α) inhibitors and interleukin inhibitors through products such as Remsima, Remsima SC (sold as Zymfentra in the U.S.), Yuflyma, Steqeyma, and Avtozma. Once CT-P55 is commercialized, revenue expansion is also expected to gain momentum. Cosentyx, the original drug, recorded global sales of approximately $6.668 billion (about 10 trillion won) last year.
"Based on our accumulated experience in biosimilar development and approval, we plan to smoothly advance the approval process for CT-P55," a Celltrion official said. "Starting with Canada, we will pursue approval procedures in major markets including the U.S. and Europe to solidify our autoimmune disease treatment portfolio and translate this into revenue growth."
