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Samsung Bioepis’ ustekinumab biosimilar Pyzchiva® (SB17) Recommended for EU Approval

Feb 22, 2024

On 22 February 2024, EU’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Samsung Bioepis’s Pyzchiva® (ustekinumab biosimilar).  Pyzchiva® is recommended for the treatment of plaque psoriasis, including paediatric plaque psoriasis, psoriatic arthritis, ulcerative colitis and Crohn’s disease in adults.  Pyzchiva® is intended to be supplied as 45 mg and 90 mg solutions for injection and a 130 mg solution for infusion.  

Pyzchiva® will be commercialised by Sandoz pursuant to a deal entered into in September 2023, between Sandoz and Samsung Bioepis for SB17 which covers the US, Canada, EEA, Switzerland and the UK.