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Accord/Dong-A ST’s Biosimilar Ustekinumab Launched in UK and Ireland

Apr 8, 2025

On 8 April 2025, The Bio reported that Dong-A ST has launched Imuldosa®, biosimilar to J&J’s Stelara® (ustekinumab) in the UK and Ireland, following its launch in Germany in January 2025.

Imuldosa® (previously known as DMB-3115) was developed jointly by Dong-A Socio Holdings and Meiji Seika Pharma and Dong A-ST acquired the development and commercialisation rights in 2020.  In July 2021, Dong-A ST signed a global out-licensing agreement with Intas Pharmaceuticals under which Intas received exclusive commercialisation rights to the ustekinumab biosimilar worldwide, excluding Japan, Korea and certain other Asian countries.

Imuldosa® received European approval in December 2024 and FDA approval in October 2024.  In October 2023, Accord BioPharma reached a settlement with Janssen that allows Accord to launch Imuldosa® in the US no later than 15 May 2025.  According to The Bio, Imuldosa is on track for a May 2025 US launch.