Dong-A ST's Stelara Biosimilar ‘IMULDOSA’ Receives Recommendation for European Marketing Authorization

Dong-A ST announced on October 21 that its Stelara biosimilar, 'IMULDOSA (project name DMB-3115, active ingredient ustekinumab),' has received a recommendation for marketing authorization approval from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA). Accord Healthcare, a subsidiary of Dong-A ST's development partner Intas, completed the Marketing Authorization Application (MAA) with EMA in June 2023 and received the CHMP's recommendation for approval on October 18. CHMP is responsible for providing scientific assessments regarding the quality, safety, and efficacy of medicines, influencing EMA's decisions.

The CHMP's recommendation plays a crucial role in the final decision by the European Commission (EC), which will determine the official marketing authorization. Dong-A ST has demonstrated its global R&D capabilities by not only obtaining this CHMP recommendation but also securing marketing authorization from the U.S.



FDA. IMULDOSA is a biosimilar of Stelara, originally developed by Janssen, and is used to treat inflammatory conditions such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. The active ingredient, ustekinumab, has achieved global sales of $20.

32 billion (IQVIA 2023 cumulative sales), making it one of the highest-grossing biologic medicines. The development of IMULDOSA began in 2013 as a joint project between Dong-A Socio Holdings and Meiji Seika Pharma. Dong-A ST has been responsible for its development and commercialization rights since July 2020.

In July 2021, Dong-A ST entered into a global licensing agreement with Intas, enabling its subsidiaries Accord Biopharma in the U.S. and Accord Healthcare in Europe and Canada to commercialize IMULDOSA.

A representative from Dong-A ST stated, "Receiving the CHMP recommendation following U.S. FDA approval reaffirms our R&D capabilities.

We look forward to a successful launch in the U.S. and European markets, providing patients with better treatment options.

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