Dong-A ST Stella-ra Similar 'Imuldosa', FDA Approval

Dong-A ST (Dong-A ST) has obtained FDA approval for Imuldoza (development name DMB-3115), developed as a biosimilar to Stelara.

Exterior view of Dong-A ST headquarters building
[Photo by Dong-A ST]

Dong-A ST announced on the 11th that Accord Biopharma, a subsidiary of Intas, an India-based multinational pharmaceutical partner company, received FDA approval for Imuldoza on the 10th (local time). It has been about a year since the FDA approval application was submitted in October last year. With this approval, Dong-A ST now holds its second FDA-approved product following Cybextro, which was approved by the FDA in 2014.

Imuldoza is a drug developed as a biosimilar to Stelara, developed by Janssen. It is used as a treatment for inflammatory diseases such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. According to IQVIA, it is a global blockbuster drug with sales of $10.86 billion (approximately 15 trillion KRW) worldwide last year.

Imuldoza has been jointly developed since 2013 by Dong-A Socio Holdings and Japan's Meiji Seika Pharma. In July 2020, the rights for development and commercialization were transferred to Dong-A ST, and since then, Dong-A ST and Meiji Seika Pharma have continued joint development. In July 2021, a global license-out agreement for Imuldoza was signed with Intas. Intas plans to commercialize Imuldoza worldwide through its subsidiaries, including Accord Biopharma in the United States and Accord Healthcare in Europe, the United Kingdom, and Canada. Accord Healthcare also applied for marketing authorization for DMB-3115 with the European Medicines Agency (EMA) in July.

Jae-Hong Park, Head of R&D at Dong-A ST, said, “The FDA approval of Imuldoza is an achievement that globally recognizes Dong-A ST’s R&D capabilities and global competitiveness. We expect Imuldoza to successfully establish itself in the United States, the world’s largest pharmaceutical market, and we will continue to strengthen our position in the global market through the development of innovative drugs.”

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