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Phase 3 Study Shows Biosimilarity of Samsung Bioepis’ SB17 (ustekinumab) to Stelara®

Apr 27, 2024

A paper published in the Journal of the American Academy of Dermatology on 27 April 2024 reported that, in a Phase 3 clinical trial sponsored by Samsung Bioepis, SB17 (ustekinumab) was biosimilar to Janssen’s Stelara® (in terms of efficacy, safety, pharmacokinetics, and immunogenicity) for the treatment of moderate to severe psoriasis.

Samsung Bioepis’ SB17 was approved in April 2024 in Europe (as Pyzchiva®) and Korea (as EpyztekTM).  Pyzchiva® will be commercialised by Sandoz in EEA, Switzerland, UK, US and Canada pursuant to a deal entered into in September 2023 between Sandoz and Samsung Bioepis.