Dong-A ST announced on November 18 that its Stelara (ustekinumab) biosimilar, "IMULDOSA" (project name DMB-3115), has received marketing authorization from the European Commission (EC).

The EC approval comes just two months after the Committee for Medicinal Products for Human Use (CHMP), an advisory body of the European Medicines Agency (EMA), recommended the approval of IMULDOSA in October. This milestone follows the U.S. Food and Drug Administration (FDA) approval granted in October, marking a significant step toward the biosimilar’s entry into the global pharmaceutical market.

IMULDOSA is a biosimilar of Stelara, a blockbuster drug developed by Janssen. Stelara is used to treat inflammatory diseases such as plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. The active ingredient, ustekinumab, is one of the world’s top-selling drugs, generating global sales of approximately USD 20.3 billion in 2023, according to market research firm IQVIA.

Development of IMULDOSA began in 2013 as a joint project between Dong-A Socio Holdings and Meiji Seika Pharma. In July 2020, development and commercialization rights were transferred to Dong-A ST to improve the efficiency of global project execution. Since then, Dong-A ST and Meiji Seika Pharma have co-developed the biosimilar.

In July 2021, Dong-A ST signed a global licensing agreement with multinational pharmaceutical company Intas. Under this agreement, Intas will commercialize IMULDOSA worldwide through its subsidiaries, including Accord Biopharma in the U.S. and Accord Healthcare in Europe, the UK, and Canada.

A Dong-A ST representative stated, "With the back-to-back approvals from the U.S. FDA and the European Commission, IMULDOSA is now one step closer to entering the global pharmaceutical market. We will do our best to ensure that IMULDOSA establishes a stable presence in the global market, providing an effective treatment option for patients around the world."

The back-to-back approvals from the U.S. and European regulators position Dong-A ST to enter the highly competitive global biosimilar market. With a proven track record of global partnerships and licensing agreements, Dong-A ST aims to capture a significant share of the growing demand for biosimilars targeting high-value biologic drugs like Stelara.