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