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