Dong-A ST announced on July 14 that the European Medicine Agency (EMA) confirmed acceptance of Marketing Authorization Application (MAA) for DMB-3115, a biosimilar of Stelara® (Ustekinumab). Accord, a wholly owned subsidiary of Intas Pharmaceuticals Ltd, submitted the MAA to EMA on June 23rd, and the EMA accepted the MMA submission on July 14th in CET. The MAA submission is based on the results of an extensive analytical similarity assessment of DMB-3115 with that US and EU-sourced STELARA using current ?state-of-the-art?

methods. The MAA submission also comprised the results from the phase III multi-regional clinical trials in patients with plaque psoriasis (NCT04785326). The primary endpoint was the rate of change in the Psoriasis Area and Severity Index (PASI) for skin symptoms. As a result, the therapeutic equivalence between DMB-3115 and the reference product was verified, and no safety issues were observed.

DMB-3115 is a proposed biosimilar to Stelara®, a blockbuster drug developed by Janssen Biotech Inc., and for plaque psoriasis, psoriatic arthritis, Crohn?s disease, and ulcerative colitis. It recorded 17.77 billion USD (IQVIA Accumulative Sales in 2022) and is one of the best-selling biologics. Dong-A Socio Holdings and Meiji Seika Pharma began joint development for DMB-3115 in 2013, and the rights for R&D and commercialization were transferred to Dong-A ST in July 2020 for efficient project management.

Since then, Dong-A ST and Meiji Seika Pharma worked together to develop the drug.