Dong-A ST Completes Phase 1 Clinical Trial in Europe for Stelara Biosimilar 'DMB-3115'

Proving Originality and Biological Equivalence

[Asia Economy Reporter Kim Ji-hee] Dong-A ST recently announced on the 4th that it has completed the Phase 1 clinical trial in Europe for the Stelara biosimilar ‘DMB-3115’.

The European Phase 1 clinical trial involved 296 healthy adults and compared the pharmacokinetic characteristics, safety, and immunogenicity of DMB-3115 with Stelara, which is used in Europe and the United States, following subcutaneous administration. As a result, DMB-3115 demonstrated bioequivalence to Stelara based on pharmacokinetic parameter criteria, and no significant differences were observed in safety and immunogenicity.

Stelara, developed by Janssen, is a biopharmaceutical that inhibits the activation of inflammatory cells by blocking the p40 subunit of immune mediators interleukin (IL)-12 and interleukin (IL)-23. It is a treatment for inflammatory diseases such as plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. According to Janssen’s management performance report last year, it recorded blockbuster sales of $7.77 billion (approximately 8.6 trillion KRW).

Dong-A Socio Holdings and Meiji Seika Pharma have been jointly developing DMB-3115 since 2013. In July last year, the rights for development and commercialization were transferred to Dong-A ST to efficiently carry out the global project, and currently, Dong-A ST and Meiji Seika Pharma are jointly developing it.

Dong-A ST initiated Phase 3 clinical trials in the United States in the first quarter of this year. In Europe, Phase 3 clinical trials have started in Poland, Estonia, and Latvia, progressing as part of the global Phase 3 clinical trials. In Europe, the trials will be conducted sequentially in a total of nine countries.

The global Phase 3 clinical trial uses clinical samples produced by DM Bio, a subsidiary of Dong-A Socio Holdings, and targets patients with moderate to severe chronic plaque psoriasis. To compare the efficacy, safety, and immunogenicity of subcutaneous administration of DMB-3115 and Stelara, the trial is conducted as a randomized, double-blind, multicenter, parallel-comparison, active-controlled study.

A Dong-A ST official stated, “The European Phase 1 clinical trial results demonstrated that the biosimilar DMB-3115 is equivalent to Stelara, which increases the likelihood of success in Phase 3 clinical trials. We plan to successfully complete the global Phase 3 clinical trials as soon as possible and supply biopharmaceuticals with excellent quality and cost-effectiveness worldwide.”

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