Celltrion's Stellara Similars Approved in Canada for the Global 28 Trillion Market

Celltrion announced on the 31st that it has received New Drug Submission (NDS) approval from Health Canada for Stekima (development code CT-P43), a biosimilar developed as a treatment for autoimmune diseases based on Stelara.

Celltrion's autoimmune disease treatment 'Stekima'
[Photo by Celltrion]

With this approval, Stekima can be used as a treatment for patients suffering from plaque psoriasis, psoriatic arthritis, Crohn's disease, and other conditions within Canada. Celltrion plans to start targeting the North American market, the world's largest pharmaceutical market, beginning with Canada, and aims to smoothly establish Stekima in the global market.

The original drug Stelara is an autoimmune disease treatment developed by Johnson & Johnson (J&J) Innovative Medicine (formerly Janssen). It treats related diseases by inhibiting inflammatory cytokines interleukin (IL)-12 and IL-23. Since the expiration of its substance patent in September last year, global competition for biosimilar development has intensified. According to IQVIA, a pharmaceutical market research firm, the global market size for ustekinumab, the main ingredient of both Stelara and Stekima, reached $20.4 billion (approximately 28.2438 trillion KRW) last year. Of this, the North American market, encompassing the United States and Canada, accounted for $16.375 billion (approximately 22.6712 trillion KRW), representing 80% of the global market. The Canadian market alone is valued at $663 million (approximately 917.9 billion KRW).

Stekima was approved last month by the Ministry of Food and Drug Safety in South Korea. In Europe, earlier this month, it received a positive opinion recommending marketing authorization from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA), and final approval is expected soon. Celltrion plans to smoothly proceed with approval processes in other major global countries to expand its market.

With this approval, Celltrion has strengthened its position and expanded its portfolio of autoimmune disease treatments in the North American market. It is expected to extend its treatment range to include IL inhibitors in addition to its existing tumor necrosis factor (TNF)-alpha inhibitor products such as Jimptetra, Remsima, and Uplima.

A Celltrion official stated, “Canada is a representative country that actively promotes biosimilar prescriptions through pro-biosimilar policies, and Celltrion’s influence, with its diverse product portfolio in Canada, will gradually increase. Furthermore, since North America is considered the largest global market for ustekinumab, we expect Stekima’s approval in Canada to be the starting point for our North American market strategy.”