FDA Approves PYZCHIVA® (ustekinumab-ttwe), Samsung Bioepis’ Biosimilar to Stelara

 

• PYZCHIVA becomes Samsung Bioepis’ seventh biosimilar and fourth immunology biosimilar approved by the FDA
• PYZCHIVA’s licensing period will begin on February 22, 2025, in the United States, based on the settlement and licensing agreement with Janssen Biotech Inc.
• PYZCHIVA will be commercialized by Sandoz in the US

https://www.biospace.com/article/releases/fda-approves-pyzchiva-ustekinumab-ttwe-samsung-bioepis-biosimilar-to-stelara/