Dong-A ST, the pharmaceutical unit of South Korean giant Dong-A Socio Holdings, has submitted a Marketing Authorization Application to the European Medicines Agency for its Stelara biosimilar DMB-3115, the company announced Wednesday.
DMB-3115 is a biosimilar to ustekinumab, also dubbed Stelara, a monoclonal antibody for the treatment of autoimmune and inflammatory diseases including Crohn’s disease, plaque psoriasis and ulcerative colitis.
First developed by Janssen Pharmaceuticals, the antibody became one of the world’s top selling drugs, having made $17.77 billion in sales worldwide as of 2022.
Once the marketing authorization is approved, it will allow DMB-3115 to be commercialized through Accord Biopharma in the US and Accord Healthcare in Europe and Canada. Dong-A ST and its Japanese partner, Meiji Seika Pharma, will manufacture DMB-3115 and supply it to Intas Pharmaceuticals for distribution.
“We are happy to announce that the application of DMB-3115 is submitted to EMA, further strengthening our vision to improve access for patients to vital biosimilars,” said Accord Healthcare Executive Vice President Paul Tredwell.
“Under our strong partnerships, Dong-A ST will strive to supply high quality DMB-3115 to global markets,” added Park Jae-hong, the president of research & development at Dong-A ST.
Since 2013, the Stelara biosimilar has been jointly developed by Dong-A ST and its Japanese partner. In 2021, the India-headquartered Intas was granted commercial rights to the biosimilar.
Through its UK subsidiary Accord Healthcare, Intas helped Dong-A ST and Meiji Seika with the EMA marketing authorization application.