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Accord Announces Launch of Stelara® (ustekinumab) Biosimilar Imuldosa®

by Robert S. Schwartz, Ph.D.
August 22, 2025

On August 18, 2025, Accord and Dong-A ST announced the U.S. launch of Imuldosa® (ustekinumab-srlf), a biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab).  Imuldosa® is approved for all the reference product’s indications, including certain patients with plaque psoriasis, active psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

According to Accord’s press release, Imuldosa® prefilled syringes will be available at the lowest wholesale acquisition cost (WAC) compared to other Stelara® biosimilars on the market, at a 92% discount to Stelara®’s WAC.  Numerous other biosimilars have launched this year, including Amgen’s interchangeable biosimilar Wezlana™ (ustekinumab-auub) on January 1, 2025 (previously reported Amgen Launches Wezlana™ as the First Stelara® Interchangeable Biosimilar through Optum’s Nuvaila), Alvotech / Teva’s interchangeable 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), Fresenius Kabi / Formycon’s interchangeable Otulfi™ (ustekinumab-aauz) on March 3, 2025, and Celltrion’s Steqeyma™ (ustekinumab-stba) on March 13, 2025 (previously reported March Stelara® Biosimilar Launches: Fresenius Kabi’s Otulfi® and Celltrion’s Steqeyma™).

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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