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March Stelara® Biosimilar Launches: Fresenius Kabi’s Otulfi® and Celltrion’s Steqeyma™

by Robert S. Schwartz, Ph.D.
March 31, 2025

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.

For more information about these and other biosimilars, please visit BiologicsHQ.

 

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The author would like to thank April Breyer Menon for her contributions to this article.

    Methodology

    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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