Dong-A ST Achieves Therapeutic Equivalence With Stelara Biosimilar

Company Aims To Submit EU and US Marketing Authorization During H1

Dong-A has achieved therapeutic equivalence for its ustekinumab biosimilar candidate DMB-3115 in clinical studies and now plans to file for marketing authorization for the product in both the EU and US.

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A global Phase III trial of 605 patients across the US and Europe has demonstrated therapeutic equivalence between Stelara (ustekinumab) and Dong-A ST’s biosimilar candidate DMB-3115.

The DMB-3115 global phase III began in the US in 2021 followed by eight European countries – including Poland, Estonia and

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