Dong-A ST's biosimilar product Imuldosa approved for U.S. market

Dong-A ST's biosimilar product Imuldosa has been approved by the U.S. Food and Drug Administration (FDA), the Korean drugmaker said Monday.

Dong-A ST headquarters [DONG-A ST]

Dong-A ST's biosimilar product Imuldosa has been approved by the U.S. Food and Drug Administration (FDA), the Korean drugmaker said Monday.

This is the second product by Dong-A ST that has received a green light from the U.S. FDA following Sivextro in 2014.

Imuldosa, which references Janssen Biotech's blockbuster drug Stelara, can be used to treat autoimmune diseases such as plague psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis, the company said.

Imuldosa has been codeveloped by Dong-A Socio Holdings and Japan's Meiji Seika Pharma since 2013 and the rights for its research and development (R&D) as well as commercialization were transferred to Dong-A ST in July 2020 for more efficiency.

In 2021, the two companies signed a global licensing agreement with U.S. Intas Pharmaceuticals which plans to commercialize the product in Europe, Britain and Canada through its subsidiaries.

"We look forward to a successful launch of Imuldosa in the United States, the world’s largest pharmaceutical market, as we continue to develop innovative medicines to further strengthen our global presence," said Dr. Park Jae-hong, head of R&D at Dong-A ST.

BY JIN EUN-SOO [jin.eunsoo@joongang.co.kr]