On 1 December 2025, Accord BioPharma announced that Express Scripts has added Imuldosa®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), to its largest commercial formularies, including National Preferred Formulary, starting 5 September 2025. Express Scripts is one of the United States’ largest pharmacy benefit managers. Accord’s announcement follows the commercial launch of Imuldosa® in the US in August 2025.
Imuldosa® was FDA-approved in October 2024. It was jointly developed by Dong-A St and Meiji Seika Pharma, which granted Intas Pharmaceuticals (Accord’s parent company) exclusive licensing rights worldwide, excluding certain Asian countries, in an agreement announced in 2021. Under the agreement, Accord is responsible for US commercialisation.
There are a number of ustekinumab biosimilars already launched in the US: Amgen’s Wezlana® (January 2025), Alvotech/Teva’s Selarsdi® (February 2025), Samsung Bioepis/Sandoz’s Pyzchiva® (February 2025), Biocon’s Yesintek® (February 2025), Formycon/Fresenius Kabi’s Otulfi® (March 2025), Celltrion’s Steqeyma® (March 2025) and Hikma’s Starjemza™ (November 2025).