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Stelara biosimilar of Dong-A ST succeeded in clinical trials

By Chon, Seung-Hyun | translator Choi HeeYoung

23.01.16 08:01:27

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Introducing the top-line results of the global phase 3

Demonstrate safety and effectiveness equivalence

Dong-A ST announced on the 16th that the Stelara biosimilar DMB-3115 has confirmed its safety and effectiveness in clinical trials. On the same day, Dong-A ST introduced the results of DMB-3115's global phase 3 clinical trial top line and announced that it would apply for item permission to the U.S. and European health authorities in the first half. Dong-A ST conducted a global phase 3 clinical trial of the Stelara biosimilar DMB-3115 on a total of 605 patients in nine countries, including the United States, Poland, and Estonia, from 2021 to the end of last year. Developed by Janssen, Stelara is a treatment for inflammatory diseases such as plate psoriasis and psoriatic arthritis, Crohn's disease, and ulcerative colitis.

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