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Dong-AST ended the clinical trial of Stelara biosimilar

By Chon, Seung-Hyun | translator Choi HeeYoung

22.11.17 09:22:41

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9 countries including the United States and Europe...Target to apply for permission in the first half of next year


 ¡ãA panoramic view of Dong-A ST headquarters

Dong-AST announced on the 17th that the global phase 3 clinical trial of Stella biosimilar DMB-3115 has ended. Phase 3 of global clinical trials of DMB-3115 was conducted for 52 weeks in a total of 605 patients in 9 countries, including Poland, Estonia, and Latvia, starting in the United States in 2021. Phase 3 of this global clinical trial was conducted with random assignment, double-blinding, multi-organ, and active-controlled trials to compare the efficacy, safety, and immunogenicity of DMB-3115 and Stelara subcutaneous injection in moderate to severe chronic plate psoriasis patients. Clinical samples produced by STGEN BIO, a biopharmaceutical CDMO affiliate of Dong-A Socio Holdings, were used.

Dong-

Chon, Seung-Hyun(1000@dailypharm.com)
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