Big Molecule Watch
July 21, 2023

EMA Accepts MAA for Dong-A ST’s Ustekinumab Biosimilar

On July 14, Dong-A ST announced that the European Medicines Agency accepted its Marketing Authorization Application (MAA) for DMB-3115, a biosimilar referencing STELARA (ustekinumab).  STELARA is approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. The MAA submission was based on the results of a phase III study in which DMB-3115 demonstrated therapeutic equivalence to STELARA in patients with plaque psoriasis.

Dong-A ST and Meiji Seika Pharma worked together to develop DMB-3115, and the worldwide distribution rights, excluding certain Asian regions, were licensed to Intas Pharmaceuticals. Intas Pharmaceuticals’ subsidiary Accord Healthcare will commercialize the product in the EU, UK, and Canada.

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