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News

Stelara® Biosimilars Launch and Licensing Dispute Begins

by Robert S. Schwartz, Ph.D.
February 28, 2025

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.

For more information about these and other biosimilars and biosimilar disputes, 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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