FDA Accepts for Review BLA for DMB-3115 of Dong-A ST, a Proposed Biosimilar to Stelara® (Ustekinumab)

– Following EMA, FDA accepted BLA for DMB-3115

SEOUL, South Korea–(BUSINESS WIRE)–#AccordBiopharma—Dong-A ST (President/CEO Min-young Kim, KRX:170900) announced that Accord BioPharma, Inc., a subsidiary of Intas Pharmaceuticals Ltd, in the United States has received a notification that the US Food and Drug Administration (“FDA”) has accepted its Biologics License Application (BLA) for DMB-3115, a proposed biosimilar to Stelara® (Ustekinumab), for substantive review.

The BLA was submitted to the FDA by Accord BioPharma on October 9, 2023 and the MAA (Marketing Authorization Application) was submitted to the EMA earlier in June 2023 by Accord Healthcare, Ltd., a European and UK subsidiary of Intas Pharmaceuticals.

The BLA leverages the analytical similarity assessment data between EU and US sourced Stelara® and DMB-3115. A global clinical Phase III trial was performed on patients with moderate-to-severe chronic plaque psoriasis. DMB-3115 displayed therapeutic equivalence with Stelara and showed no statistically significant difference in safety.

Stelara®, developed by Janssen Biotech Inc., is a blockbuster drug approved to treat inflammatory diseases such as plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. It recorded USD 17.77 billion in sales (IQVIA Accumulative Sales) in 2022 and is one of the world’s best-selling biologics.

Dong-A Socio Holdings and Meiji Seika Pharma began joint development of DMB-3115 in 2013. The rights of Dong-A Socio Holdings for R&D and commercialization were transferred to Dong-A ST in July 2020 for efficient project management. Since then, Dong-A ST and Meiji Seika Pharma worked together to develop the drug.

In July 2021, Dong-A ST signed a global license-out contract with Intas Pharmaceuticals. Intas Pharmaceuticals plans to commercialize DMB-3115 through Accord BioPharma (US), Accord Healthcare (EU, UK, and Canada), and other subsidiaries around the world. Dong-A ST and Meiji Seika Pharma are responsible for DMB-3115 R&D and will exclusively supply the product to Intas Pharmaceuticals, Accord BioPharma, and Accord Healthcare.

Jae-Hong Park, CSO of Dong-A ST, stated, “The DMB-3115 marketing application for the US has been submitted following the submission in the EU by leveraging therapeutic equivalence and safety data between DMB-3115 and Stelara®,” adding, “We will spare no efforts in working with Intas Pharmaceuticals through the remaining application process to supply DMB-3115 to the global markets, such as the US and the EU.”

Contacts

Shin-Hee Park

+82-32-610-2481

sh-park@donga.co.kr

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