1. Generics Bulletin

Dong-A Makes It Five: Accord Gears Up For US Launch After Ustekinumab Approval

Settlement Date Provides Certainty Of Launch; Amgen’s US Launch Only Months Away

 
• By Dean Rudge

Partners Dong-A ST and Meiji Seika Pharma have demonstrated their credentials in the US biosimilar market, bagging a US Food and Drug Administration approval for their biosimilar Stelara product that will be commercialized by Accord Healthcare.

Approved stamp on application form or business agreement document
(Shutterstock) • Source: Shutterstock

Intas Pharmaceuticals’ Accord Healthcare can begin preparations to launch its US biosimilar Stelara (ustekinumab) product next year, after the US Food and Drug Administration gave the green light to development partners Dong-A ST/Meiji Seika Pharma’s Imuldosa (ustekinumab-srlf) version – the fifth US biosimilar to Johnson & Johnson’s blockbuster IL-12/IL-23 inhibitor.

Imuldosa’s approval was based on the positive results of a Phase III efficacy, safety and immunogenicity clinical trial involving more than 600 patients with moderate to severe chronic plaque...

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