TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

WEZLANA

USTEKINUMAB-AUUB Interleukin-12 Antagonists
Immunology Approved 2023-10-31

Wezlana is a human interleukin-12 and -23 antagonist indicated for the treatment of several chronic inflammatory conditions in both adult and pediatric populations. In adults, it is used to treat moderate to severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active Crohn's disease or ulcerative colitis. Pediatric patients aged 6 years and older may receive the treatment for moderate to severe plaque psoriasis and active psoriatic arthritis. It is specifically indicated for psoriasis patients who are candidates for phototherapy or systemic therapy.

Source: FDA Label • Amgen • Interleukin-12 Antagonist

How WEZLANA Works

Wezlana is a monoclonal antibody that binds to the p40 protein subunit shared by the IL-12 and IL-23 cytokines. By targeting this subunit, the drug prevents these cytokines from interacting with the IL-12Rβ1 receptor on the surface of cells. This disruption inhibits signaling cascades that lead to natural killer cell activation and T-cell differentiation. This mechanism addresses the chronic inflammation that characterizes immune-mediated diseases like Crohn's disease and ulcerative colitis.

Source: FDA Label
2
Indications
--
Phase 3 Trials
2
Years on Market

Details

Status
Prescription
First Approved
2023-10-31
Routes
INTRAVENOUS, SUBCUTANEOUS
Dosage Forms
INJECTABLE

Companies

Active Ingredient: USTEKINUMAB-AUUB

WEZLANA Approval History

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What WEZLANA Treats

4 indications

WEZLANA is approved for 4 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Plaque Psoriasis
  • Psoriatic Arthritis
  • Crohn's Disease
  • Ulcerative Colitis
Source: FDA Label

WEZLANA Target & Pathway

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Target

IL-23 (Interleukin-23) Cytokine

A cytokine that promotes Th17 cell development and maintenance. IL-23 is upstream of IL-17 in the inflammatory cascade driving psoriasis and inflammatory bowel disease. Blocking IL-23 provides sustained control of these conditions.

Auto-substitute OK for Stelara

Pharmacists can substitute WEZLANA for Stelara without calling the prescriber. This is a lower-cost alternative with no clinically meaningful differences.

WEZLANA Competitors

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6 other drugs also target IL-12. Compare mechanisms, indications, and trial activity.

Drug = Competitor name Company = Manufacturer N indic. = FDA-approved indications → Date = Patent/exclusivity expiry

Competitors share the same molecular target (IL-12). Earlier expiry dates signal biosimilar/generic opportunities.

Drugs Similar to WEZLANA

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

CYLTEZO
ADALIMUMAB-ADBM
4 shared
Boehringer Ingelheim
Shared indications:
Psoriatic ArthritisCrohn's DiseaseUlcerative Colitis +1 more
OTULFI
USTEKINUMAB-AAUZ
4 shared
Fresenius Kabi
Shared indications:
Plaque PsoriasisPsoriatic ArthritisCrohn's Disease +1 more
PYZCHIVA
USTEKINUMAB-TTWE
4 shared
SAMSUNG BIOEPIS CO LTD
Shared indications:
Plaque PsoriasisPsoriatic ArthritisCrohn's Disease +1 more
REMICADE
INFLIXIMAB
4 shared
Johnson & Johnson
Shared indications:
Crohn's DiseaseUlcerative ColitisPsoriatic Arthritis +1 more
YESINTEK
USTEKINUMAB-KFCE
4 shared
BIOCON BIOLOGICS INC
Shared indications:
Plaque PsoriasisPsoriatic ArthritisCrohn's Disease +1 more
YUFLYMA
ADALIMUMAB-AATY
4 shared
CELLTRION
Shared indications:
Psoriatic ArthritisCrohn's DiseaseUlcerative Colitis +1 more
AMJEVITA
ADALIMUMAB-ATTO
3 shared
Amgen
Shared indications:
Psoriatic ArthritisCrohn's DiseaseUlcerative Colitis
CIMZIA
CERTOLIZUMAB PEGOL
3 shared
UCB INC
Shared indications:
Crohn's DiseasePsoriatic ArthritisPlaque Psoriasis
HULIO
ADALIMUMAB-FKJP
3 shared
Viatris
Shared indications:
Psoriatic ArthritisUlcerative ColitisPlaque Psoriasis
HUMIRA
ADALIMUMAB
3 shared
AbbVie
Shared indications:
Psoriatic ArthritisUlcerative ColitisPlaque Psoriasis
HYRIMOZ
ADALIMUMAB-ADAZ
3 shared
Novartis
Shared indications:
Psoriatic ArthritisCrohn's DiseaseUlcerative Colitis
IDACIO
ADALIMUMAB-AACF
3 shared
Fresenius Kabi
Shared indications:
Psoriatic ArthritisUlcerative ColitisPlaque Psoriasis
IMULDOSA
USTEKINUMAB-SRLF
3 shared
ACCORD BIOPHARMA INC.
Shared indications:
Plaque PsoriasisPsoriatic ArthritisUlcerative Colitis
SELARSDI
USTEKINUMAB-AEKN
3 shared
ALVOTECH USA INC
Shared indications:
Plaque PsoriasisPsoriatic ArthritisUlcerative Colitis
SIMLANDI
ADALIMUMAB-RYVK
3 shared
ALVOTECH USA INC
Shared indications:
Psoriatic ArthritisUlcerative ColitisPlaque Psoriasis
STARJEMZA
ustekinumab-hmny
3 shared
BIO-THERA SOLUTIONS LTD
Shared indications:
Plaque PsoriasisPsoriatic ArthritisUlcerative Colitis
STELARA
USTEKINUMAB
3 shared
Johnson & Johnson
Shared indications:
Plaque PsoriasisPsoriatic ArthritisUlcerative Colitis
ABRILADA
ADALIMUMAB-AFZB
2 shared
Pfizer
Shared indications:
Psoriatic ArthritisUlcerative Colitis
AVSOLA
INFLIXIMAB-AXXQ
2 shared
Amgen
Shared indications:
Crohn's DiseaseUlcerative Colitis
BIMZELX
BIMEKIZUMAB-BKZX
2 shared
UCB INC
Shared indications:
Plaque PsoriasisPsoriatic Arthritis
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

WEZLANA FDA Label Details

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Indications & Usage

FDA Label (PDF)

WEZLANA is a human interleukin -12 and -23 antagonist indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. active psoriatic arthritis (PsA) . moderately to severely active Crohn's disease (CD) . moderately to severely active ulcerative colitis. Pediatric patients 6 years and older with: moderate to severe plaque psoriasis (PsO) , who are candidates for phototherapy or systemic therapy. active psoriatic arthritis (PsA) . 1.1 Plaque Psoriasis (PsO) WEZLANA is indicated for the treatment of adults a...

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.