Celltrion files for Canadian approval of Cosentyx biosimilar CT-P55, targeting North American market

Celltrion has launched its push into the North American market with a biosimilar candidate targeting one of the world's largest autoimmune disease drugs — a blockbuster franchise valued at roughly 10 trillion won ($6.65 billion).

The South Korean biopharmaceutical company said Monday it filed for regulatory approval of CT-P55, a biosimilar candidate for the autoimmune drug Cosentyx (secukinumab), with Health Canada.

The filing seeks approval across all indications the original drug holds in Canada, including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis.

The application is supported by clinical data from a trial involving 172 healthy volunteers. CT-P55 demonstrated pharmacokinetic equivalence to the reference product and showed meaningful similarity in safety and immunogenicity profiles.

The addition of CT-P55, an interleukin (IL)-17A inhibitor, is expected to further strengthen Celltrion's autoimmune disease portfolio. The company already markets a lineup of tumor necrosis factor-alpha (TNF-α) inhibitors — Remsima, Remsima SC (sold in the United States as Zymfentra) and Yuflyma — and has expanded into interleukin inhibitors with Steqeyma and Eptozimab, building broad coverage across treatment classes.

Canada was chosen as the first market for the filing in part because of its actively pro-biosimilar policy environment, which encourages prescribing and adoption of biosimilars. Celltrion plans to use a Canadian approval as a springboard into the broader North American market and then pursue sequential regulatory filings in the United States, Europe and South Korea to accelerate commercialization.

The sales growth potential expected upon successful commercialization is also significant. Cosentyx, the reference product, posted global sales of approximately $6.67 billion (about 10 trillion won) last year.

"Drawing on our accumulated biosimilar R&D and regulatory experience, we will guide CT-P55 through the approval process smoothly," a Celltrion official said. "We will solidify our autoimmune disease treatment portfolio and translate that into tangible sales growth."

Celltrion is executing a mid-to-long-term road map to expand its current lineup of 11 marketed biosimilars to 18 by 2030. The company is advancing a pipeline of follow-on candidates at various stages of development, including biosimilars for Ocrevus (CT-P53) and Taltz (CT-P52) in the autoimmune segment, and biosimilars for Keytruda (CT-P51) and Darzalex (CT-P44) in the anticancer drug segment.