Dong-A ST Secures European Approval for Stelara Biosimilar IMULDOSA [Yahoo! Finance]
Johnson & Johnson (JNJ)
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Source: Yahoo! Finance
SEOUL, South Korea, December 19, 2024 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
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