European Medicine Agency accepts Intas' marketing authorisation application for DMB-3115, a proposed biosimilar to Stelara (ustekinumab)

Intas Pharmaceuticals

14 July 2023 - Therapeutic equivalence and safety confirmed between DMB-3115 and Stelara in global Phase III trial.

Intas Pharmaceuticals announced that the EMA confirms acceptance of the marketing authorisation application for DMB-3115, a biosimilar of Stelara (ustekinumab).

Read Intas Pharmaceuticals press release

Michael Wonder

Posted by:

Michael Wonder

Posted in:

Medicine , Europe , Biosimilar , Dossier