Dong-A ST announced on the 19th that 'IMULDOSA' (development name DMB-3115, active ingredient ustekinumab), developed as a biosimilar to Stelara, has been officially launched in the U.S. market. Local distribution and sales are handled by partner companies Intas Pharmaceuticals and Accord Biopharma.

Dong-A ST's IMULDOSA is a biosimilar product to Stelara, developed by Janssen, and is used for the treatment of inflammatory diseases such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. The original Stelara is a blockbuster drug with annual global sales reaching approximately USD 21.552 billion (about KRW 29.9422 trillion, based on IQVIA 2024 data).

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

A Dong-A ST representative stated, "With the launch of IMULDOSA in the U.S. following Europe, the pace of global market entry is accelerating," and added, "We will do our best to establish IMULDOSA as an effective treatment option for patients worldwide."

Meanwhile, IMULDOSA has been jointly developed by Dong-A Socio Holdings and Japan's Meiji Seika Pharma since 2013. In July 2020, the development and commercialization rights were transferred to Dong-A ST. In July 2021, a global license-out agreement for IMULDOSA was signed with global pharmaceutical company Intas. Intas is commercializing IMULDOSA through Accord Biopharma in the U.S. and Accord Healthcare in Europe, the UK, and Canada.

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