Sandoz And Samsung Celebrate Stelara Rival’s EU Approval

Pyzchiva Biosimilar Version Of Ustekinumab Receives European Commission Nod

 
• By Dave Wallace

Sandoz and Samsung Bioepis have received final European Commission approval for their partnered Pyzchiva biosimilar rival to Stelara. But with European competition on ustekinumab due to kick off in just a matter of months, further applicants are also waiting in the wings.

Red wooden figure waiting second in line with other wooden figures
Sandoz and Samsung's Pyzchiva is the second of many ustekinumab biosimilar filings to receive approval in the EU • Source: Shutterstock

Sandoz and Samsung Bioepis have received final European Commission approval for their partnered Pyzchiva (ustekinumab) rival to Stelara, following the biosimilar’s endorsement by the European Medicines Agency’s Committee for Medicinal Products for Human Use earlier this year (see sidebar).

Sandoz said that Pyzchiva– which it licenses from Samsung Bioepis under a deal struck last September that, along with the European Economic Area, also covers the US, Canada, Switzerland and the UK (Also see "Sandoz Fills Pipeline Gap With Samsung Bioepis’ Ustekinumab" - Generics Bulletin, 11 September, 2023

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