On 24 February 2025, Sandoz announced the US launch of Pyzchiva® (ustekinumab-ttwe), biosimilar to J&J/Janssen’s Stelara®. On the same date, Biocon Biologics announced the US launch of Yesintek™ (ustekinumab-kfce/Bmab 1200).
Pyzchiva® was developed by Samsung Bioepis and is commercialised by Sandoz in the US pursuant to a deal entered into in September 2023. The US FDA approved Pyzchiva® in July 2024 for multiple indications, including plaque psoriasis, active psoriatic arthritis, Crohn’s disease and ulcerative colitis.
Yesintek™ was approved in the US in early December 2024 for the same indications.
The timing of both the Pyzchiva® and Yesintek™ launches was governed by settlement and licence agreements between Janssen and the biosimilar sponsors to resolve US litigation/Inter Partes Review Petitions. Samsung Bioepis entered an agreement in July 2023 (announced in November 2023), permitting launch of Pyzchiva® in the US from 22 February 2025. Biocon entered its settlement with Janssen in February 2024, permitting launch of Yesintek™ from February 2025.
The US-launches of Pyzchiva® and Yesintek™ follow those of Alvotech/Teva’s Selarsdi® on 21 February 2025 and Amgen’s Wezlana® in early January 2025 (through Optum Health Solution’s private label subsidiary Nuvaila).