By end of August, the US Food and Drug Administration (FDA) has approved three ustekinumab biosimilars.  They are: Samsung Bioepis’ Pyzchiva (ustekinumab-ttwe) [1], Alvotech's Selarsdi (ustekinumab-aekn) marketed by Teva [2], and Amgen’s Wezlana (ustekinumab-auub), the first interchangeable ustekinumab biosimilar approved by the FDA [3].

Ustekinumab is a humanized monoclonal antibody that interferes with the triggering of the body’s inflammatory response through the suppression of certain cytokines; it is a human interleukin (IL)–12 and IL-23 antagonist. The originator, Stelara, is approved for indications including treatment of Crohn's disease, plaque psoriasis, psoriatic arthritis, and ulcerative colitis [4].

The ustekinumab biosimilar will be produced by Evernorth's affiliate private label distributor Quallent Pharmaceuticals and will be available in early 2025. The US$0 out-of-pocket cost will be part of Quallent's Copay Assistance Program, and it is estimated to save patients an average of US$4,000 per year. Currently, more than 30,000 Accredo patients use Stelara.

In addition, the biosimilar's price will be approximately 80% lower than Stelara's list price, which would generate significant savings for employers and other plan sponsors that contract with Accredo.

This follows the news announced in April 2024 that Evernorth also made an interchangeable biosimilar of AbbVie’s Humira (adalimumab) available at US$0 out-of-pocket cost for eligible patients of Accredo. This was estimated to save patients $3,500 per year [5], and more than 25% of eligible Accredo patients are now using the biosimilar.

Related article
Boehringer and GoodRx make Humira biosimilar available at 92% discount

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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves third ustekinumab biosimilar Pyzchiva [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 8]. Available from: www.gabionline.net/biosimilars/news/fda-approves-third-ustekinumab-biosimilar-pyzchiva
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves ustekinumab, trastuzumab, and tocilizumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 8]. Available from: www.gabionline.net/biosimilars/news/fda-approves-ustekinumab-trastuzumab-and-tocilizumab-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable ustekinumab biosimilar Wezlana [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 8]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-ustekinumab-biosimilar-wezlana
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ustekinumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 8]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-ustekinumab
5. GaBI Online - Generics and Biosimilars Initiative. Disruption in the US adalimumab market [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 8]. Available from: www.gabionline.net/biosimilars/general/disruption-in-the-us-adalimumab-market

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