2026.01.29

Dong-A ST announced on January 28 that its Stelara biosimilar, ‘IMULDOSA’ (development code DMB-3115, ustekinumab), has obtained marketing approval from Health Canada.

IMULDOSA is a biosimilar to Stelara, originally developed by the multinational pharmaceutical company Johnson & Johnson Innovative Medicine (formerly Janssen). The reference product has generated global sales of approximately USD 21.552 billion (based on 2024 estimates from IQVIA).

IMULDOSA is actively advancing its global market expansion, having been launched in 19 countries, including the United States, Germany, the United Kingdom, and Ireland. In addition, the product has obtained marketing approval across Middle East and North Africa (MENA) markets, including Saudi Arabia, Qatar, and the United Arab Emirates.

"The marketing approval granted in Canada once again validates IMULDOSA's competitiveness on the global stage. Through close collaboration with our global partners, we will continue to ensure a stable supply and advance commercialization efforts in key international markets," a Dong-A ST official said.

IMULDOSA was co-developed by Dong-A Socio Holdings and Meiji Seika Pharma beginning in 2013. To facilitate efficient execution of the global development and commercialization strategy, the associated rights were transferred to Dong-A ST in July 2020. Subsequently, in July 2021, a global licensing agreement for IMULDOSA was concluded with the multinational pharmaceutical company Intas Pharmaceuticals. Under this agreement, Intas Pharmaceuticals is commercializing IMULDOSA worldwide through its affiliates, including Accord BioPharma in the U.S. and Accord Healthcare in Europe, the United Kingdom, and Canada.

Source : Dong-A ST secures Canadian approval for Stelara biosimilar ‘Imuldosa’ < ENGLISH NEWS < 기사본문 - 더바이오