Three Stelara® (ustekinumab) biosimilars launched in the U.S. in the past week, Alvotech / Teva’s Selarsdi™ (ustekinumab-aekn) on February 21, 2025, and Sandoz / Samsung Bioepis’s Pyzchiva® (ustekinumab-ttwe) and Biocon’s Yesintek™ (ustekinumab-kfce) on February 24, 2025. These launches follow the January 1, 2025 launch of Amgen’s interchangeable biosimilar Wezlana™ (ustekinumab-auub) through Optum’s Nuvalia (previously reported Amgen Launches Wezlana™ as the First Stelara® Interchangeable Biosimilar through Optum’s Nuvaila). Selarsdi™ and Pyzchiva® have been approved as provisionally interchangeable, subject to Wezlana™’s interchangeable exclusivity. Discounts from Stelara®’s wholesale acquisition costs are 80% for Pyzchiva®, 81% for Wezlana™, 85% for Selarsdi™, and 90% for Yesintek™. Sandoz / Samsung Bioepis have signed a private-label deal with an undisclosed pharmacy benefit manager (PBM) for distribution of Pyzchiva®.
Numerous other Stelara® biosimilars are set to launch soon. Under settlement agreements, Fresenius Kabi / Formycon’s Otulfi™ (ustekinumab-aauz) could have launched as of February 22, 2025, so launch may be imminent. Celltrion’s Steqeyma™ (ustekinumab-stba) can launch as early as March 7, 2025, and Accord / Intas’s Imuldosa® (ustekinumab-srlf) as early as May 15, 2025. Bio-Thera awaits approval of an aBLA for BAT2206, accepted by the FDA in July 2024.
On the same day of Pyzchiva®’s launch, Johnson & Johnson sued Samsung Bioepis (Case No. 2:25-cv-01439 (D.N.J.)) for an alleged breach of a settlement licensing agreement by sublicensing to an undisclosed company to distribute an additional private-label version of Pyzchiva®. The lawsuit seeks a preliminary injunction against the sales of this private-label product alleging that irreparable harm including significant erosion of Stelara®’s market share could result from the breach. Johnson & Johnson also seeks a permanent injunction and compensatory damages.
Johnson & Johnson reported Stelara® U.S. sales of $6.72B in 2024.
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The author would like to thank April Breyer Menon for her contributions to this article.
