Dong-A ST Completes FDA Approval Application for 'Stelara Similar' in the US

Dong-A ST (Dong-A ST) has completed the U.S. approval application for 'DMB-3115,' a biosimilar of the autoimmune disease treatment 'Stelara' (active ingredient ustekinumab) developed by the company.

Exterior view of Dong-A ST headquarters building
Photo by Dong-A ST

Dong-A ST announced on the 5th that Accord Biopharma, a U.S. subsidiary of Intas, a multinational pharmaceutical company to which DMB-3115 was technology-exported, has completed the Biologics License Application (BLA) for DMB-3115 with the U.S. Food and Drug Administration (FDA). This came about three months after submitting the application to the FDA in October last year. Another Intas subsidiary, Accord Healthcare, had already completed the approval application for DMB-3115 with the European Medicines Agency (EMA) in July last year.

This FDA approval application for DMB-3115 was based on the results of a Phase 3 clinical trial demonstrating quality equivalence with the original drug in patients with moderate to severe chronic plaque psoriasis in the U.S. and Europe. The primary efficacy endpoint was set as the percentage change from baseline in the Psoriasis Area and Severity Index (PASI). As a result, DMB-3115 demonstrated therapeutic equivalence to Stelara, and no significant differences in safety were observed.

Stelara is an interleukin (IL)-12 and IL-23 inhibitor developed by Janssen (a Johnson & Johnson subsidiary). It is a blockbuster product used to treat autoimmune diseases such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. The substance patent for Stelara expired in the U.S. last September and is expected to expire in Europe in July. According to IQVIA, a pharmaceutical market research firm, the global ustekinumab market size reached $17.7 billion (approximately 23 trillion KRW) in 2022, making it one of the highest-grossing drugs worldwide.

Accordingly, Dong-A Socio Holdings and Meiji Seika Pharma have been jointly developing DMB-3115 since 2013. In 2020, to efficiently carry out the global project, the development and commercialization rights holder on Dong-A's side was changed to Dong-A ST, and joint development with Meiji Seika Pharma has continued.

In 2021, through a global license-out agreement with Intas for DMB-3115, exclusive rights for approval and sales in global regions excluding some Asian countries such as Korea and Japan were transferred. Intas plans to commercialize DMB-3115 worldwide through its subsidiaries, including Accord Biopharma in Europe, the UK, and Canada, and Accord Healthcare. Dong-A ST and Meiji Seika Pharma will conduct research and development of DMB-3115 and exclusively supply the product to Intas, Accord Biopharma, and Accord Healthcare.

Jae-Hong Park, Head of R&D at Dong-A ST, said, “Based on the therapeutic equivalence and safety between DMB-3115 and Stelara, we have completed the approval application for DMB-3115 in the U.S. following Europe. We will work closely with Intas to expedite DMB-3115's entry into global markets such as Europe and the U.S. and do our best to proceed with the remaining procedures.”

This content was produced with the assistance of AI translation services.