Dong-A ST’s IMULDOSA™ (ustekinumab-srlf), a Biosimilar to STELARA®, receives approval from US FDA

Dong-A ST (http://en.donga-st.com/Main.da) (President/CEO Jae-Hun Jung, KRX: 170900) announced on October 11 that Imuldosa™ (usteki-numab-srlf/DMB-3115), a biosimilar referencing Stelara®, has won U.S. Food and Drug Administration (FDA) approval.

As its second FDA-approved biosimilar after Sivextro® (tedizolid phosphate) in 2014, the company has once again demonstrated its R&D competence.

The news comes following the FDA acceptance of the biologics license application (BLA) submitted by Ac-cord BioPharma, a wholly-owned subsidiary of Intas Pharmaceuticals, in October 2023.

Imuldosa is a biosimilar to Stelara, a blockbuster drug developed by Janssen Biotech Inc. for the treatment of patients with autoimmune diseases such as plaque psoriasis, psoriatic arthritis, Crohn’s disease and ul-cerative colitis. It is one of the highest-grossing biopharmaceuticals generating US$10.86 billion globally (IQVIA Accumulative Sales in 2023).

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 li-cense agreement with Intas Pharmaceuticals, who is set to commercialize the biosimilar with its global sub-sidiaries 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 Medi-cines Agency (EMA) in June 2023, which was accepted in the following month of July 2023.

Dr. Jae-Hong Park, the Head of R&D at Dong-A ST commented, “This FDA approval indicates global recog-nition 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.”

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