The U.S. Food and Drug Administration (FDA) has approved Dong-A ST’s Imuldosa (ustekinumab-srlf/DMB-3115), a biosimilar referencing Stelara.
Imuldosa is a biosimilar to Stelara which is approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. Ustekinumab blocks interleukin (IL)-12 and -23.
Dong-A Socio Holdings and Meiji Seika Pharma began joint development for Imuldosa in 2013, and the rights for R&D and commercialization were transferred from Dong-A Socio Holdings to Dong-A ST in July 2020 for efficient project management. In July 2021, Dong-A ST and Meiji Seika Pharma signed a global license agreement with Intas Pharmaceuticals, who is set to commercialize the biosimilar with its global subsidiaries including Accord BioPharma of the US and Accord Healthcare of the EU, UK, and Canada. Accord Healthcare has also submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) in June 2023, which was accepted in the following month of July 2023.
“We look forward to a successful launch of Imuldosa in the U.S., the world’s largest pharmaceutical market, as we continue to develop innovative medicines to further strengthen our global presence,” says Dr. Jae-Hong Park, the Head of R&D at Dong-A ST, in a news release.
The FDA has approved several other Stelara biosimilars including Wezlana (Amgen), Pyzchiva (Samsung Bioepis), Selarsdi (Teva Pharmaceuticals, Alvotech), and Otulfi (Formycon and Fresenius Kabi).
