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News

Amgen Launches Wezlana™ as the First Stelara® Interchangeable Biosimilar through Optum’s Nuvaila

by Robert S. Schwartz, Ph.D.
January 16, 2025

On January 1, 2025, Amgen launched the first interchangeable biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab), Wezlana™ (ustekinumab-auub), as a private label product through Optum Health’s Nuvaila.  According to Optum’s formulary, Wezlana™ for Nuvaila will be available in low-wholesale acquisition cost (WAC) and high-WAC versions.  Wezlana™’s interchangeability designation will allow pharmacies to switch patients without intervention from their prescriber, subject to state laws.  Wezlana™ will be placed on the same formulary tier as Stelara®.

Along with this launch, Optum also updated its formulary with respect to Humira® (adalimumab) and its biosimilars.  Previously Optum had offered Humira® along with Amgen’s Amjevita™ (adalimumab-atto), Boehringer Ingelheim’s Cyltezo® (adalimumab-adbm) and unbranded adalimumab-adbm, and Sandoz’s Hyrimoz® (adalimumab-adaz) and unbranded adalimumab-adaz.  As of January 1, 2025, Optum will only cover the privately labeled Amjevita™ for Nuvaila (low-WAC) and Amjevita™ for Amgen (high-WAC) for new patients.  Humira® (for new patients) and all other branded and unbranded biosimilars will be excluded from the formulary.  Existing patients will continue to have coverage for Humira®.

Numerous other Stelara® biosimilars are poised to launch in the coming months, including Alvotech / Teva’s Selarsdi™ (ustekinumab-aekn), Samsung Bioepis / Sandoz’s Pyzchiva® (ustekinumab-ttwe), Fresenius Kabi / Formycon’s Otulfi™ (ustekinumab-aauz) and Biocon’s Yesintek™ (ustekinumab-kfce) in February 2025, Celltrion’s Steqeyma™ (CT-P43) (ustekinumab-stba) in March 2025, and Accord’s Imuldosa™ (ustekinumab-srlf) in May 2025.

There are currently no pending patent disputes related to Stelara® biosimilars.

Johnson & Johnson reported Stelara® U.S. sales of $6.97B in 2023.

For more information on these biosimilars and other biosimilar launches, please visit BiologicsHQ.com.

 

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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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