Dong-A ST Completes Phase 3 Trial of Biosimilar 'DMB-3115'

Donga ST Headquarters Exterior (Photo by Donga ST)

[Asia Economy Reporter Chunhee Lee] Dong-A ST announced on the 17th that the global Phase 3 clinical trial of the Stelara (active ingredient ustekinumab) biosimilar (biopharmaceutical generic) ‘DMB-3115’ has been completed.

This clinical trial was initiated sequentially in nine countries, including the United States starting last year, Poland, Estonia, and Latvia, involving 605 patients over approximately one year. Clinical samples produced by STGenbio, a contract development and manufacturing organization (CDMO) specialized subsidiary of Dong-A Socio Holdings, were used in a randomized, double-blind, multicenter, parallel-group, active-controlled trial comparing the efficacy, safety, and immunogenicity of DMB-3115 and Stelara subcutaneous injection (SC) in patients with moderate to severe chronic plaque psoriasis.

Dong-A ST plans to analyze the global Phase 3 clinical trial results and, if positive data are obtained, submit a marketing authorization application for DMB-3115 in the United States and Europe in the first half of next year.

Since 2013, Dong-A Socio Holdings has been jointly developing DMB-3115 with Meiji Seika Pharma. In 2020, to efficiently carry out the project, the rights for development and commercialization were transferred to Dong-A ST, which has been jointly developing the product with Meiji Seika Pharma.

In July last year, a global license-out agreement for DMB-3115 was signed with the multinational pharmaceutical company Intas. According to the contract, exclusive rights for approval and sales in global regions excluding Korea, Japan, and some Asian countries were transferred to Intas. Subsequently, global commercialization will be handled by Accord Healthcare, a subsidiary of Intas. Dong-A ST and Meiji Seika Pharma will be responsible for the research and development (R&D) and exclusive supply of DMB-3115.

Janssen (a subsidiary of Johnson & Johnson)'s autoimmune disease treatment 'Stelara' (generic name 'Ustekinumab')

Stelara, developed by Janssen, a subsidiary of Johnson & Johnson, is a treatment for autoimmune diseases such as psoriasis, arthritis, Crohn’s disease, and ulcerative colitis. According to Janssen, it was a blockbuster drug with sales of $9.134 billion (approximately 12 trillion KRW) last year alone. Since the substance patent expires in the United States in September next year and in Europe in July 2024, fierce competition in biosimilar development is underway ahead of the biosimilar market opening. Currently, in addition to Celltrion, Samsung Bioepis, Dong-A ST, Amgen, and Alvotech are also developing biosimilars.

Among overseas big pharma companies, Amgen was the first to succeed in Phase 3 clinical trials. In April, Amgen announced that the Phase 3 clinical trial of ‘ABP-654’ met the primary efficacy endpoints and confirmed no clinically meaningful differences compared to the original drug. Amgen began additional clinical trials last year to obtain approval for an 'interchangeable biosimilar' designation beyond a simple biosimilar. If designated as interchangeable, pharmacists can substitute the original drug independently, gaining an advantage in competition with other biosimilars. Moreover, even if the original developer tries to maintain market share by expanding indications, extrapolation to other indications of the original drug is possible, allowing easier response.

Alvotech also announced in May that the Phase 3 clinical trial results of the biosimilar ‘AVT-04’ met the primary endpoints and confirmed equivalence to Stelara.

In Korea, Celltrion and Samsung Bioepis are also pursuing biosimilar development. Celltrion disclosed in September that ‘CT-P43’ confirmed equivalence in efficacy and similarity in safety to Stelara in Phase 3 clinical trials. Samsung Bioepis started a Phase 3 clinical trial of ‘SB17’ in July last year, targeting 464 psoriasis patients across eight countries.

Kim Min-young, CEO of Dong-A ST, said, “Since the global Phase 3 clinical trial of DMB-3115 was completed within the planned schedule, our goal is to promptly derive results and apply for marketing authorization in the United States and Europe in the first half of next year.” He added, “By successfully completing this clinical trial, we will demonstrate Dong-A ST’s capabilities in biopharmaceutical research and development (R&D) and lead the development of biopharmaceuticals with excellent quality and cost-effectiveness.”