On 28 January 2026, Korea Biomedical Review reported that Dong-A ST’s Imuldosa®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), has received marketing approval from Health Canada.
Imuldosa® has already been launched in 19 countries, including the UK and Ireland (April 2025) and the US (August 2025). It has also obtained marketing approval in the Middle East and North Africa region, including Saudi Arabia, Qatar, and the United Arab Emirates.
Imuldosa® (previously known as DMB-3115) was developed jointly by Dong-A Socio Holdings and Meiji Seika Pharma and Dong A-ST acquired the development and commercialisation rights in 2020. In July 2021, Dong-A ST signed a global out-licensing agreement with Intas Pharmaceuticals under which Intas received exclusive commercialisation rights to the ustekinumab biosimilar worldwide, excluding Japan, Korea and certain other Asian countries. Intas is commercialising Imuldosa® through its global affiliates, including Accord BioPharma in the US and Accord Healthcare in Europe, the UK, and Canada.
A number of ustekinumab biosimilars have been approved and launched in Canada to date, including JAMP/Alvotech’s Jamteki® (approved November 2023, launched March 2024), Amgen’s Wezlana® (approved December 2023, launched March 2024), Celltrion’s Steqeyma® (approved July 2024, launched August 2024), Samsung Bioepis’ Pyzchiva™ (approved August 2024), Fresenius’ Otulfi® (approved December 2024, launched May 2025) and Biocon’s Yesintek™ (approved October 2025).