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Stelara

(ustekinumab)

Stelara (ustekinumab) binds the p40 subunit shared by IL-12 and IL-23, blocking both Th1 and Th17 inflammatory pathways. Cornerstone therapy for psoriasis, psoriatic arthritis, and IBD. J&J transitioning patients to Skyrizi as biosimilars approach.

Immunology$9.8B RevenueMature — Biosimilar entry 2025
Years on Market
15+
Peak Revenue
$10.8B (2022)
Approved Indications
4
Biosimilar Launch
2025 (US)

Drug Overview

Generic Name
ustekinumab
Company
Johnson & Johnson
Mechanism
IL-12/IL-23 p40 subunit inhibitor
Drug Class
Monoclonal antibody — IL-12/23 inhibitor
Route
Subcutaneous injection / IV infusion (initial)
Approval Year
2009
Peak Sales Estimate
Historical peak $10.8B (2022)
Patent Expiry
2025 (US) — biosimilars launching

How It Works

Stelara binds p40 shared by IL-12 and IL-23, preventing receptor binding. Blocks both Th1 (IL-12) and Th17 (IL-23) inflammatory pathways, providing broad immune modulation.

Revenue History ($B)

Annual revenue trajectory

Competitor Revenue Comparison ($B)

Revenue of competing drugs in the same class

Approved Indications

4 indications

Key Indications

All approved therapeutic uses

Plaque Psoriasis
Psoriatic Arthritis
Crohn’s Disease
Ulcerative Colitis

Market Position

Stelara has been a top-3 immunology biologic for a decade. Biosimilar launch in 2025 will erode revenue. J&J is actively transitioning patients to Tremfya (IL-23 selective) to retain franchise value.

Future Outlook

Revenue declining as biosimilars launch 2025. J&J’s Tremfya + Skyrizi (licensed to AbbVie) represent the IL-23 successor strategy. Stelara will remain significant through 2026 but in managed decline.

Competitive Landscape

DrugCompanyRevenue
Skyrizi (risankizumab)AbbVie$7.7B
Tremfya (guselkumab)J&J$3.0B
Cosentyx (secukinumab)Novartis$5.0B
Taltz (ixekizumab)Eli Lilly$2.8B

Approval Timeline

Sep 2009
Plaque psoriasis
FDAModerate-to-severe adults
Sep 2013
Psoriatic arthritis
FDAActive PsA
Sep 2016
Crohn’s disease
FDAModerate-to-severe
Oct 2019
Ulcerative colitis
FDAModerate-to-severe

Key Clinical Trials

NCT05536341Completed
UNITI-1/2 (Crohn’s)
Phase 31,281 patients
Significant remission
NCT05438234Completed
UNIFI (Ulcerative colitis)
Phase 3961 patients
Positive remission
Data Sources

Revenue figures from company annual reports (FY2023). Clinical trial data from ClinicalTrials.gov. Competitive intelligence from Evaluate Pharma World Preview 2024 and IQVIA MIDAS. Market analysis by Medifirm Intelledge Global.