FDA approves Dong-A ST’s Stelara biosimilar
Dong-A-ST's Imuldosa (ustekinumab-srlf/DMB-3115), a biosimilar to Stelara, has won the Food and Drug Administration’s approval.
“This FDA approval indicates global recognition of Dong-A ST’s R&D excellence and global competitiveness. 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,” said Dong-A ST’s president and CEO Jae-Hun Jung.
The news comes following the FDA acceptance of the biologics license application submitted by Accord BioPharma, a wholly-owned subsidiary of Intas Pharmaceuticals, in October 2023.
Imuldosa is a biosimilar to Stelara, a blockbuster drug developed by Janssen Biotech for the treatment of patients with autoimmune diseases such as plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. It is one of the highest-grossing biopharmaceuticals generating $10.86 billion globally, per IQVIA accumulative sales data in 2023.
[Read more: Fresenius Kabi, Formycon receive FDA nod for Stelara biosimilar]
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 U.S. and Accord Healthcare of the EU, UK and Canada.
Accord Healthcare also has submitted a marketing authorization application to the European Medicines Agency in June 2023, which was accepted in the following month of July 2023.
[Read more; Evernorth to offer Stelara biosimilar at $0 out of pocket for patients early next year]
Jae-Hong Park, head of R&D at Dong-A ST said, “This FDA approval indicates global recognition of Dong-A ST’s R&D excellence and global competitiveness. 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.”