Dong-A ST wins European approval for Stelara biosimilar IMULDOSA

Dong-A ST said Wednesday that its Stelara biosimilar, IMULDOSA (project name DMB-3115, ingredient: ustekinumab), has received marketing authorization from the European Commission (EC).

The approval came approximately two months after receiving a positive recommendation from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) in October, following the U.S. FDA approval in the same month, completing the preparations for its global market entry.

IMULDOSA is a biosimilar of Stelara, developed by Janssen Biotech, used to treat inflammatory diseases such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

Ustekinumab, the active ingredient in Stelara, is one of the highest-grossing biologic drugs globally, with cumulative sales of $20.32 billion as of 2023.

IMULDOSA was jointly developed by Dong-A Socio Holdings and Meiji Seika Pharma since 2013. In July 2020, Dong-A ST took over R&D and commercialization responsibilities to streamline global project management, with ongoing development in collaboration with Meiji Seika Pharma.

In July 2021, Dong-A ST entered into a global licensing agreement with Indian multinational pharmaceutical company Intas Pharmaceuticals Limited. Intas plans to commercialize IMULDOSA through its subsidiaries, including Accord BioPharma in the U.S. and Accord Healthcare, which handles large-scale generic pharmaceuticals across Europe, the U.K., and Canada.