Celltrion said on the 1st that it has applied to Health Canada for marketing approval of CT-P55, a biosimilar to the autoimmune disease treatment Cosentyx (ingredient secukinumab).
Cosentyx is an interleukin (IL)-17A inhibitor developed by Switzerland's Novartis and is used to treat autoimmune diseases such as ankylosing spondylitis, psoriatic arthritis, and moderate to severe plaque psoriasis. Last year's global sales were about $6.668 billion (Hanwha 10 trillion won).
For CT-P55, Celltrion applied for approval in Canada for all indications approved for Cosentyx, including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and juvenile idiopathic arthritis.
The application was based on the results of a clinical trial conducted in 172 healthy adults. In the trial, CT-P55 demonstrated pharmacokinetic (PK) equivalence to Cosentyx and showed similar results in safety and immunogenicity.
After completing the Canadian approval process, Celltrion plans to speed commercialization by expanding applications to major countries, including the United States, Europe, and Korea. In particular, it plans to use Canada, which actively encourages the adoption of biosimilars, as a base for targeting the North American market.
If CT-P55 is launched, Celltrion's autoimmune disease treatment portfolio is expected to be further strengthened. Celltrion currently has Remsima, Remsima SC (U.S. product name Zymfentra), Yuflyma, Steqeyma, and Abtozma, building a portfolio that spans tumor necrosis factor alpha (TNF-α) inhibitors and interleukin inhibitors.
A Celltrion official said, "We plan to smoothly push ahead with the approval process for CT-P55 based on the biosimilar development and approval experience we have accumulated," adding, "Starting with Canada, we will follow approval procedures in key global markets, including the United States and Europe, to solidify our autoimmune disease treatment portfolio and link it to tangible sales growth."