On March 3, 2025, Fresenius Kabi and Formycon announced the launch of Otulfi™ (ustekinumab-aauz), a provisionally interchangeable biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab), subject to the interchangeable exclusivity of Amgen’s Wezlana™ (ustekinumab-auub).
On March 13, 2025, Celltrion announced the launch of its Stelara® biosimilar Steqeyma™ (ustekinumab-stba), at an 85% discount to Stelara®’s wholesale acquisition cost. Celltrion has secured a listing agreement with Costco Health Solutions for Steqeyma™ to be designated as a preferred drug on its formulary, and Stelara® will be removed from Costco’s formulary.
These launches follow February’s wave of Stelara® biosimilar launches, including Alvotech / Teva’s Selarsdi™ (ustekinumab-aekn) on February 21, 2025, Sandoz / Samsung Bioepis’s Pyzchiva® (ustekinumab-ttwe) and Biocon’s Yesintek™ (ustekinumab-kfce) on February 24, 2025 (previously reported Stelara® Biosimilars Launch and Licensing Dispute Begins). Accord / Intas may launch its Stelara® biosimilar Imuldosa® (ustekinumab-srlf) as early as May 15, 2025.
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.
