2024-07-31 12:05:28
Health Canada Approves ‘Stekima’ Product License
Canada introduces biosimilar-friendly policy
Patent agreement finalized with Janssen… “Expecting rapid launch upon approval in major countries”
North American market size: approximately 22 trillion won
Celltrion announced on the 31st that it had received approval for ‘Stekima (CT-P43),’ a biosimilar of Stelara (ingredient name: ustekinumab), from Health Canada.
With this approval, Celltrion Stekima can now be sold locally in Canada for indications such as plaque psoriasis, psoriatic arthritis, and Crohn’s disease. Canada is considered a bridgehead for advancing into the U.S., a key market in North America, geographically. Starting with Canada, Celltrion plans to accelerate its advance into the North American market and smoothly settle into the ustekinumab market.
According to IQVIA, a pharmaceutical market research firm, the global ustekinumab market size last year was approximately KRW 26.52 trillion. Of this, Canada is not large at KRW 861.9 billion, but the entire North American market, including the US, is KRW 21.2875 trillion. It accounts for over 80% of the global market.
Currently, Stekima has completed the application for product approval in the United States. In Korea, it received approval last month. In Europe, it received a ‘recommendation for approval’ opinion from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA). Approval in major regions is proceeding smoothly. Since the agreement on patents with the original drug developer Janssen has also been finalized, it is expected that a quick launch will be possible if product approval is granted.
Obtaining approval for Stekima is significant in terms of strengthening Celltrion’s product portfolio. It can strengthen its market position and position along with expanding its portfolio of autoimmune disease treatments. In particular, in the autoimmune disease treatment area, it is expected that the overall area will naturally expand as it is the first time that an interleukin (IL) inhibitor product has been added to the existing tumor necrosis factor (TNF-α) inhibitor product group such as Remsima, Remsima SC, and Uplyma. Celltrion also expects that the target patient range for treatment will be greatly expanded.
A Celltrion official said, “Canada is a representative country with a pro-biosimilar policy that actively encourages biosimilar prescriptions, and we expect the influence of the Celltrion brand, which has a variety of products in the local market, to gradually increase,” adding, “Furthermore, it is significant in that it is the starting point for our strategy to conquer North America, which is considered the world’s largest market.”
Celltrion has recently been gaining a presence in the global market by obtaining product approvals for its follow-up pipelines, including Omriclor, Stekima, and Idenzelt. Expectations for strengthening market dominance and expanding performance are also rising. Celltrion plans to secure a biosimilar portfolio of 11 products by 2025.
Kim Min-beom, Donga.com reporter [email protected]
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2024-07-31 12:05:28