Dong-A ST: "Stelara Biosimilar Imuldesa Receives Marketing Authorization in Canada"
by Lee Sungmin
Published 28 Jan.2026 11:04(KST)
"Global Competitiveness Reaffirmed"
Dong-A ST announced on January 28 that its Stelara biosimilar, Imuldesa (ingredient: ustekinumab), has received marketing authorization from Health Canada.
Imuldesa is a Stelara biosimilar jointly developed by Dong-A ST and Meiji Seika Pharma. In July 2021, Dong-A ST signed a licensing-out agreement for Imuldesa with the multinational pharmaceutical company Intas. Since then, Intas has been commercializing Imuldesa through its global affiliates, including Accord Biopharma in the United States and Accord Healthcare in Europe, the United Kingdom, and Canada.
The original drug, Stelara, recorded global sales of approximately USD 21.552 billion (about KRW 31 trillion) in the global pharmaceutical market as of 2024, making it a blockbuster product. Imuldesa is currently available in 19 countries, including the United States, Germany, the United Kingdom, and Ireland, and is expanding its presence in the global market by obtaining marketing authorizations in the Middle East and North Africa (MENA) region, such as Saudi Arabia, Qatar, and the United Arab Emirates (UAE).
A Dong-A ST representative stated, "By obtaining marketing authorization in Canada, we have once again confirmed Imuldesa's global competitiveness," adding, "We plan to continue ensuring stable supply and commercialization in key markets through cooperation with our global partners."
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