On 23 February 2024, Samsung Bioepis presented two new study results for ustekinumab SB17 (biosimilar to Janssen’s Stelara®) at the 19th Congress of European Crohn’s and Colitis Organisation (ECCO) in Stockholm, Sweden. The results demonstrate SB17 is highly similar to Stelara® in structural, physicochemical, and biological attributes. On 25 February 2024, CHMP provided a positive recommendation for SB17.
The medicine will be commercialised by Sandoz in the US, Canada, EEA, Switzerland and the UK under an exclusive commercialisation agreement entered in September 2023.