The Medical Letter on Drugs and Therapeutics
In Brief: Wezlana — An Ustekinumab Biosimilar Interchangeable with Stelara
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Med Lett Drugs Ther. 2024 Jul 22;66(1707):119   doi:10.58347/tml.2024.1707e
 Select a term to see related articles  biosimilars   Crohn's disease   Finlius   Jamteki   psoriasis   Stelara   ulcerative colitis   ustekinumab   Wezlana 

The FDA has approved ustekinumab-auub (Wezlana – Amgen), an interchangeable biosimilar product similar to the interleukin-12 and -23 antagonist Stelara, for treatment of the same indications as Stelara (see Table 1). Wezlana is the first Stelara biosimilar to be approved in the US.

A biosimilar is a biologic product that is highly similar in composition, potency, and biologic properties to and has no clinically meaningful differences in safety, purity, and potency from the FDA-approved reference product. For a biosimilar to be approved as an interchangeable product, the manufacturer generally conducts clinical trials to prove that the results will be the same if the patient switches between the reference product and the biosimilar. In clinical studies, there were no clinically significant differences in efficacy and safety between Wezlana and Stelara for treatment of moderate to severe plaque psoriasis. The FDA extrapolated approval of Wezlana to psoriatic arthritis, Crohn's disease, and ulcerative colitis based on available data.1-3

According to federal law, an interchangeable product can be substituted for the reference product by the pharmacist without permission from the prescriber. Some states require the pharmacist to notify the prescriber and/or patient before making the substitution; currently four states (AL, IN, SC, and WA) restrict interchangeability entirely.4

Wezlana will be launched in early 2025 when Stelara's patent exclusivity expires. The cost of the drug is not yet available, but will presumably be less expensive than Stelara. The wholesale acquisition cost (WAC) for a 12-week supply of Stelara for treatment of plaque psoriasis for a 75-kg patient is about $13,300 and for treatment of Crohn's disease or ulcerative colitis is about $26,500.5

  1. V Chow et al. Pharmacokinetic similarity of ABP 654, an ustekinumab biosimilar candidate: results from a randomized, double-blind study in healthy subjects. Clin Pharmacol Drug Dev 2023; 12:863. doi:10.1002/cpdd.1301
  2. G Cantin et al. Analytical and functional similarity of the biosimilar candidate ABP 654 to ustekinumab reference product. Drugs R D 2023; 23:421. doi:10.1007/s40268-023-00441-7
  3. NIH. A study to investigate ABP 654 for the treatment of participants with moderate to severe plaque psoriasis. Available at: Accessed June 19, 2024.
  4. S Humphreys. Understanding interchangeable biosimilars at the federal and state levels. Am J Manag Care 2023; 29:SP545. doi:10.37765/ajmc.2023.89419
  5. Approximate WAC. WAC = wholesaler acquisition cost or manufacturer’s published price to wholesalers; WAC represents a published catalogue or list price and may not represent an actual transactional price. Source: AnalySource® Monthly. June 5, 2024. Reprinted with permission by First Databank, Inc. All rights reserved. ©2024.
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