Dong-A ST said on the 28th that the autoimmune disease treatment "IMULDOSA" (ingredient name ustekinumab) obtained marketing authorization from Health Canada. IMULDOSA is a biosimilar of Janssen's "Stelara."
A company official said, "Based on cooperation with our global partners, we plan to continue stable supply and commercialization in key markets."
IMULDOSA has been launched in a total of 19 countries, including the United States, Germany, the United Kingdom, and Ireland. It obtained marketing authorization in Middle East and North Africa (MENA) countries such as Saudi Arabia, Qatar, and the United Arab Emirates
IMULDOSA has been jointly developed by Dong-A Socio Holdings and Meiji Seika Pharma since 2013. In July 2020, the rights for development and commercialization were transferred to Dong-A ST, and Dong-A ST and Meiji Seika Pharma have continued development.
In July 2021, it was transferred to the multinational pharmaceutical company Intas. Intas is commercializing IMULDOSA through its global affiliates, including Accord Biopharma in the United States and Accord Healthcare in Europe, the United Kingdom, and Canada.