Dong-A ST said Accord Biopharma, a subsidiary of Intas Pharmaceutical, has received approval for the latter's biologics license application (BLA) for DMB-3115, a biosimilar referencing Stelara (ingredient: ustekinumab) to the FDA.

Accord Biopharma had previously submitted the application to the FDA in October 2023.

DMB-3115 was jointly developed by Dong-A Socio Holdings and Meiji Seika Pharma in 2013, and in July 2020, the rights for development and commercialization were transferred to Dong-A ST for efficient global project execution. Dong-A ST and Meiji Seika Pharma continued joint development.

In July 2021, a global license-out agreement for DMB-3115 was signed with multinational pharmaceutical company Intas. Intas planned to commercialize DMB-3115 through its global affiliates, including Accord Biopharma in the U.S. and Accord Healthcare in Europe, the U.K., and Canada.

Under the accord, Dong-A ST and Meiji Seika Pharma will handle the research and development of DMB-3115 and exclusively supply the product to Intas, Accord Biopharma, and Accord Healthcare.

This BLA submission is based on the results of an analytical similarity assessment between Stelara and DMB-3115 in the U.S. and Europe. The global phase 3 clinical trial, conducted on patients with moderate to severe chronic plaque psoriasis, demonstrated that DMB-3115 has therapeutic equivalence to Stelara, and no significant differences in safety were observed.

"Based on the therapeutic equivalence and safety between DMB-3115 and Stelara, Intas has completed the BLA application in the U.S., following Europe," Dong-A ST President of Research and Development Park Jae-hong said. "We will work closely with Intas to expedite the remaining procedures and enter the global market, including Europe and the U.S., as soon as possible."

Stelara, developed by Janssen, is a treatment for inflammatory diseases such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. It is one of the highest-grossing biopharmaceuticals in the world, with IQVIA data showing that the treatment recorded $17.7 billion in sales in 2022.