Therapeutic equivalence and safety confirmed between DMB-3115 and Stelara in global phase III

Intas Pharmaceuticals Ltd. announced that the European Medicine Agency (EMA) confirms acceptance of the Marketing Authorization Application (MAA) for DMB-3115, a biosimilar of Stelara® (Ustekinumab). The MAA has been submitted by Accord Healthcare, a wholly owned subsidiary of Intas Pharmaceuticals Ltd. on June 23rd, and the EMA accepted the MAA submission on 14th July.

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 from Dong-A Socio Holdings to Dong-A ST in July 2020 for efficient project management. In July 2021, Dong-A ST and Meiji Seika Pharma signed an exclusive, global license agreement with Intas Pharmaceuticals and granted exclusive worldwide commercialization rights excluding Korea, Japan, and some Asian countries. Intas Pharmaceuticals is set to commercialize DMB-3115 with its global subsidiaries – Accord BioPharma of the US and Accord Healthcare of the EU, UK, and Canada.

The MAA submission is based on 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.

“We are truly excited by this partnership which, besides strengthening our existing biosimilar portfolio, also reinforces our long-term commitment towards bettering access to world-class biosimilar drugs for patients globally,” said Mr Binish Chudgar, Vice Chairman and Managing Director of Intas Pharmaceuticals Ltd.

Mr. Paul Tredwell, Executive Vice President of Accord Healthcare said, We are delighted to reinforce our partnership with Dong-a & Meiji for Accord Healthcare to file for global rights to this critical drug reinforcing our commitment to improving access to high-quality biosimilar drugs for patients globally. A spokesperson for Dong-A ST stated, “We will spare no effort to ensure DMB-3115 is supplied to the global market. 

DMB-3115 is a proposed biosimilar to Stelara® which is a blockbuster drug developed by Janssen Biotech Inc. for plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. It recorded USD 17.77 billion USD (IQVIA Accumulative Sales in 2022) and is one of the best-selling biologics.