Dong-A ST Secures European Approval for Stelara Biosimilar IMULDOSA

- Global Market Expansion Accelerates with Back-to-Back FDA and EC Authorizations

SEOUL, South Korea--(BUSINESS WIRE)--Dong-A ST (CEO: Jeong Jae-hoon, KRX: 170900) proudly announces that its Stelara biosimilar, IMULDOSA (Project Name: DMB-3115, Active Ingredient: Ustekinumab), has received marketing authorization from the European Commission (EC) as of December 18.

This landmark approval comes just two months after the Committee for Medicinal Products for Human Use (CHMP) under the European Medicine Agency (EMA) recommended the product for approval in October. Combined with its successful U.S. Food and Drug Administration (FDA) approval in October, IMULDOSA is now fully authorized to enter the global market.

IMULDOSA, a biosimilar referencing Stelara of Janssen Pharmaceuticals, is indicated for treating inflammatory diseases, including plaque psoriasis, psoriatic arthritis, and Crohn’s disease.

Stelara, with its active ingredient ustekinumab, is among the top-grossing biologics worldwide, generating $20.323 billion in cumulative global sales in 2023, according to IQVIA.

The development of IMULDOSA began in 2013 as a joint project between Dong-A Socio Holdings and Meiji Seika Pharma. In July 2020, the development and commercialization rights held by Dong-A Socio Holdings were transferred to Dong-A ST to ensure the efficient execution of the global project. Since then, Dong-A ST and Meiji Seika Pharma have continuously collaborated to develop it.

In July 2021, Dong-A ST signed a global out-licensing agreement with multinational pharmaceutical company Intas Pharmaceuticals for IMULDOSA. Through Intas and its subsidiaries, including Accord Biopharma in the United States and Accord Healthcare in Europe, the UK, and Canada, IMULDOSA is set to be launched in multiple regions.

A representative for Dong-A ST commented, “With the consecutive approvals in the United States and Europe, IMULDOSA is now one step closer to entering the global pharmaceutical market. We will continue to dedicate our efforts to ensure that IMULDOSA establishes a strong presence in the market, providing an effective treatment option to patients worldwide.”