EMA accepts MAA for Dong-A ST’s Stelara biosimilar, DMB-3115

Dong-A ST, the South Korean pharmaceutical company, has received confirmation from the European Medicine Agency (EMA) of the acceptance of their Marketing Authorization Application (MAA) for DMB-3115, a biosimilar of Stelara (ustekinumab).

The MAA was submitted to the EMA by Accord, a subsidiary of Intas Pharmaceuticals, on June 23rd, and the agency accepted the submission on July 14th.

The MAA is built on comprehensive analytical similarity assessments of DMB-3115 with the US and EU-sourced Stelara, utilizing advanced methods. It also encompasses results from phase III clinical trials with patients suffering from plaque psoriasis. The primary measure was the variation in the Psoriasis Area and Severity Index (PASI), which examines skin symptoms. Consequently, DMB-3115’s therapeutic equivalence with the reference product was confirmed, and no safety issues were identified.

DMB-3115 is a proposed biosimilar to Stelara, a drug by Janssen Biotech, used for treating plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. In 2022, it achieved sales of $17.77 billion (according to IQVIA Accumulative Sales) and is among the top-selling biologics.

The development of DMB-3115 began as a joint venture between Dong-A Socio Holdings and Meiji Seika Pharma in 2013. In July 2020, the R&D and commercialization rights were transferred to Dong-A ST. Since then, Dong-A ST and Meiji Seika Pharma have collaborated on developing the drug.

In July 2021, global distribution rights for DMB-3115, excluding Japan, South Korea, and some Asian regions, were licensed to Intas Pharmaceuticals. Intas, through its subsidiaries Accord BioPharma in the US and Accord Healthcare in the EU, UK, and Canada, will commercialize DMB-3115.

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.” DongA ST’s President & CSO, Jaehong Park, pledged that “we will spare no effort to ensure DMB-3115 is supplied to the global market by leveraging a strong partnership between Dong-A, Meiji, Intas, and Accord.”