Dong-A ST Launches Stelara Biosimilar 'IMULDOSA' in the United States

Dong-A ST announced on August 19 that it has launched the Stelara biosimilar 'IMULDOSA' (project name DMB-3115, active ingredient ustekinumab) in the United States through its partners, multinational pharmaceutical companies Intas and Accord Biopharma.

Exterior view of Dong-A ST headquarters. Photo by Dong-A ST

IMULDOSA is a biosimilar of Stelara, originally developed by Janssen, and is used to treat inflammatory diseases such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

Last year, Stelara recorded global sales of approximately $21.552 billion (about KRW 29.9314 trillion).

IMULDOSA has been launched in a total of 14 countries, including Germany, the United Kingdom, and Spain. In the MENA region, including Saudi Arabia, Qatar, and the United Arab Emirates, it has obtained marketing authorization.

A Dong-A ST representative stated, "With the launch of IMULDOSA in the United States following Europe, our entry into the global market is accelerating. We will do our utmost to ensure that IMULDOSA becomes an effective treatment option for patients worldwide."

Meanwhile, IMULDOSA was jointly developed by Dong-A Socio Holdings and Meiji Seika Pharma starting in 2013. In July 2020, the rights for development and commercialization were transferred to Dong-A ST for more efficient global project management, and Dong-A ST and Meiji Seika Pharma have since continued joint development.

In July 2021, Dong-A ST signed a global license-out agreement for IMULDOSA with multinational pharmaceutical company Intas. Intas is commercializing IMULDOSA worldwide through its affiliates, including Accord Biopharma in the United States and Accord Healthcare in Europe, the United Kingdom, and Canada.

This content was produced with the assistance of AI translation services.