On 25 May 2025, Biocon Biologics announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Yesintek®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab). Yesintek® is indicated for treatment of adults and children from 6 years with moderate to severe plaque psoriasis and adults with active psoriatic arthritis or moderately to severely active Crohn’s disease.
The European Commission granted marketing authorisation for Yesintek™ in February 2025. In the same month, Biocon launched Yesintek® in the US, following its US approval in early December 2024.
In August 2024, Biocon announced that it had signed a patent settlement and licence agreement with Janssen which enables Biocon to commercialise Bmab 1200/Yesintek® in Europe, the United Kingdom, Canada and Japan (launch date unknown).
There are a number of ustekinumab biosimilars already approved in the UK, including Dong A-ST/Intas’ Imuldosa® (launched April 2025), Formycon/Fresenius’ Otulfi®/FYB202 (approved January 2025), Celltrion’s Steqeyma® (approved September 2024), Samsung Bioepis’ Pyzchiva® (approved May 2024), STADA’s Uzpruvo® (approved March 2024) and Amgen’s Wezenla™ (approved January 2024).