Wezlana (ustekinumab-auub) — FDA-Approved Biosimilar to Stelara (ustekinumab)

IL-12/23 Inhibitor Biosimilar · Approved 2023 · $0–$35/mo for most insured patients

🔬 What Is Wezlana?

Wezlana (ustekinumab-auub) is an FDA-approved biosimilar to Stelara (ustekinumab). A biosimilar is a biological medication that is highly similar to an already-approved reference biologic, with no clinically meaningful differences in safety, purity, or potency. Wezlana (ustekinumab-auub) is the first FDA-approved Stelara biosimilar from Amgen, launching after the Stelara patent expiry. It targets both IL-12 and IL-23 and is approved for all Stelara indications — psoriasis, PsA, Crohn's disease, and ulcerative colitis.

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Wezlana Overview

Property	Details
Brand Name	Wezlana
Generic Name	ustekinumab-auub
Reference Biologic	Stelara (ustekinumab)
Manufacturer	Amgen
Drug Class	IL-12/23 Inhibitor Biosimilar
FDA Approval	2023
Route	Subcutaneous injection
Approved Conditions	Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, Ulcerative Colitis
Copay Program	Amgen SupportPlus — $0–$35/mo for most insured patients

Approved Conditions

✓Plaque Psoriasis✓Psoriatic Arthritis✓Crohn's Disease✓Ulcerative Colitis

Wezlana vs Stelara (ustekinumab)

Wezlana has been demonstrated to be biosimilar to Stelara (ustekinumab) through comprehensive analytical, non-clinical, and clinical studies. The FDA requires that biosimilars have no clinically meaningful differences from the reference product. Patients who are stable on Stelara (ustekinumab) should discuss any potential switch to Wezlana with their prescriber.

Factor	Wezlana	Stelara (ustekinumab)
FDA Status	Biosimilar (approved 2023)	Reference biologic
Active Ingredient	ustekinumab-auub	ustekinumab
Mechanism	IL-12/23 Inhibitor	Same
Approved Indications	Same as Stelara (ustekinumab)	Multiple FDA-approved
Typical Patient Cost	$0–$35/mo for most insured patients	$0–$35/mo (varies by plan)

Yes. The FDA requires biosimilars to demonstrate there are no clinically meaningful differences in safety, purity, and potency compared to the reference product. Wezlana underwent rigorous clinical studies demonstrating biosimilarity to Stelara (ustekinumab). Your prescriber can discuss whether Wezlana is appropriate for your specific situation.

Many patients do switch from reference biologics to biosimilars. The decision should be made in consultation with your prescriber. Switching is generally safe for stable patients, but your doctor may want to monitor you during the transition. BiologicHealthPlus can coordinate the prior authorization for Wezlana and ensure a seamless supply transition.

Most commercial insurance plans and Medicare Part D cover Wezlana with prior authorization. In many cases, Wezlana may have a lower tier placement on formularies than Stelara (ustekinumab), potentially reducing your copay. BiologicHealthPlus verifies your insurance coverage, handles all prior authorization, and enrolls you in the Amgen SupportPlus copay program to minimize your out-of-pocket costs.

Without insurance, Wezlana costs approximately $5500/month at list price — lower than Stelara (ustekinumab)'s list price. Uninsured or underinsured patients may qualify for patient assistance through Amgen SupportPlus. BiologicHealthPlus will find every available savings option for you at no charge.

📚 Sources & Further Reading

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FDA Biosimilar ApprovalsFDA

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BiosimilarWikipedia

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ACR Biosimilar PositionACR

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Biosimilar DevelopmentNIH/NCBI

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Medicare Biosimilar CoverageCMS

Medical Disclaimer: Educational content reviewed by BiologicHealthPlus Clinical Team. Last reviewed: August 2026.

Medical Disclaimer: This page is for informational purposes only. Wezlana requires a valid prescription. Consult your physician before making any changes to your medication. Last updated: August 2026.