On August 28, 2026, the U.S. Food and Drug Administration (FDA) approved a supplemental Biologics License Application (sBLA) for Stelara (ustekinumab injection, Janssen Biotech, Inc.; BLA 761044 / BLA 125261) for the treatment of moderately to severely active ulcerative colitis in pediatric patients aged 2 years and older. The milestone follows the agency's April 15, 2026 approval of Stelara for pediatric Crohn's disease in the same age group. According to the FDA Center for Drug Evaluation and Research (CDER) announcement, Stelara is now the first approved therapeutic monoclonal antibody that does not target human tumor necrosis factor alpha (TNF-alpha) for the two main forms of pediatric inflammatory bowel disease (IBD).
For pediatric gastroenterology practices, health plan pharmacy and therapeutics (P&T) committees, pharmacy benefit managers (PBMs), and specialty pharmacies navigating ustekinumab loss of exclusivity (LOE), this regulatory action introduces a critical operational wedge:
Does an expanded pediatric ulcerative colitis indication on originator Stelara automatically translate into coverage or automatic pharmacy substitution for interchangeable biosimilars like Wezlana, and how should access teams manage utilization management criteria while federal labeling indexes lag?
The direct operational answers govern clinical utilization and prior authorization (PA) workflows:
- Originator indication only: The August 28 license is a labeled indication expansion for originator Stelara. It does not amend the licensed indications of ustekinumab biosimilars.
- Wezlana Structured Product Labeling (SPL) remains adult-only for IBD: Live openFDA records for Amgen's interchangeable biosimilar Wezlana (ustekinumab-auub,
effective_time20260603) restrict Crohn's disease and ulcerative colitis indications strictly to adult patients. Wezlana's pediatric labeling is limited to moderate-to-severe plaque psoriasis and active psoriatic arthritis in patients aged 6 years and older. - No automatic pharmacy substitution in pediatric IBD: FDA interchangeability designations apply on a presentation- and indication-specific basis. Under state pharmacy substitution laws, a retail or specialty pharmacist cannot legally auto-substitute an interchangeable biosimilar for an off-label pediatric indication. A prescription for a 7-year-old child with ulcerative colitis written for Stelara cannot be dispensed as Wezlana at the pharmacy counter without prescriber re-authorization.
- DailyMed and Drugs@FDA indexing lag: As of August 31, 2026, live openFDA / DailyMed SPL records for Stelara (setid
c77a9664-e3bb-4023-b400-127aa53bca2b,effective_time20260721) still reflect adult-only ulcerative colitis in section 1.4. In Drugs@FDA, the latest indexed Efficacy Action for BLA 761044 remains Supplement 20 (dated 2026-04-15 for pediatric Crohn's). Electronic PA (ePA) engines scraping DailyMed must be manually configured to prevent erroneous pediatric denials during this transition. - Formulary step edits require immediate carve-outs: Payers enforcing mandatory biosimilar-first step therapy (e.g., "must try and fail preferred ustekinumab biosimilar") must carve out pediatric patients aged 2 to 17 with ulcerative colitis and Crohn's disease, or risk forcing patients through off-label biosimilar hurdles.
┌──────────────────────────────────────────────────────────────────────────────────────────────────┐
│ STELARA PEDIATRIC UC REGULATORY & BIOSIMILAR SPL SCORECARD │
├──────────────────────────┬───────────────────────────────────────────────────────────────────────┤
│ Dimension / Parameter │ Regulatory Fact / Current Documented Status │
├──────────────────────────┼───────────────────────────────────────────────────────────────────────┤
│ Action Date & Authority │ August 28, 2026; FDA CDER News & Regulatory Action Notice │
│ Sponsor / Application │ Janssen Biotech, Inc. (BLA 761044 / BLA 125261) │
│ Labeled Indication │ Moderately to severely active ulcerative colitis in pediatrics ≥2 yrs │
│ Mechanism of Action │ Interleukin-12 and Interleukin-23 (IL-12/IL-23) p40 antagonist mAb │
│ Class Distinction │ 1st non-TNF mAb approved for both pediatric Crohn's & UC │
│ Regulatory Precedent │ Complements April 15, 2026 pediatric Crohn's disease sBLA (≥2 yrs) │
│ Special Designations │ Orphan Drug Designation (ODD) for pediatric ulcerative colitis │
│ Pivotal Trial Support │ UNIFI Jr (NCT04630028, N=112, ages 3–17) + adult UC + pediatric CD PK │
│ Wezlana Biosimilar SPL │ openFDA 20260603: CD/UC restricted to adults; Ped (≥6y) for PsO/PsA │
│ Purple Book Substitution │ State-law substitution barred for off-label pediatric indications │
│ Repository Lag (8/31/26) │ DailyMed SPL effective 20260721 still adult UC; Drugs@FDA AP 04/2026 │
│ Medicare IRA Status │ Selected drug; bona fide marketing deselection effective Jan 1, 2027 │
└──────────────────────────┴───────────────────────────────────────────────────────────────────────┘
What Did FDA Actually License on August 28 vs. the April 15 Crohn's sBLA?
The August 28, 2026 approval of Stelara for pediatric ulcerative colitis completes Janssen's regulatory lifecycle expansion across pediatric inflammatory bowel disease.
The Pediatric IBD Approval Timeline
The regulatory sequence established by FDA CDER bridges adult registrational data with dedicated pediatric pharmacokinetic, safety, and clinical cohorts:
- Pediatric Crohn's Disease (April 15, 2026): FDA approved Stelara for moderately to severely active Crohn's disease in pediatric patients aged 2 years and older (BLA 761044, Efficacy Supplement 20). The August 28 news page restates that license as the first half of Stelara's pediatric IBD pair.
- Pediatric Ulcerative Colitis (August 28, 2026): FDA approved Stelara for moderately to severely active ulcerative colitis in pediatric patients aged 2 years and older. This sBLA was supported by safety and effectiveness extrapolation from adequate and well-controlled adult UC trials, pharmacokinetic (PK) and safety bridging from pediatric Crohn's patients aged 2 to 17 years, and dedicated 52-week clinical and PK data from UNIFI Jr.
┌──────────────────────────────────────────────────────────────────────────────────────────────────┐
│ STELARA PEDIATRIC IBD INDICATION EXPANSION MAP │
├───────────────────────┬───────────────────────────────────┬──────────────────────────────────────┤
│ Clinical Parameter │ Pediatric Crohn's Disease │ Pediatric Ulcerative Colitis │
├───────────────────────┼───────────────────────────────────┼──────────────────────────────────────┤
│ Approval Date │ April 15, 2026 │ August 28, 2026 │
│ Regulatory Pathway │ sBLA (BLA 761044 / SUPPL 20) │ sBLA (BLA 761044 / BLA 125261) │
│ Labeled Age Band │ Patients aged 2 years and older │ Patients aged 2 years and older │
│ Disease Severity │ Moderately to severely active CD │ Moderately to severely active UC │
│ Target Class │ IL-12/23 p40 monoclonal antibody │ IL-12/23 p40 monoclonal antibody │
│ Orphan Status │ Not restated on Aug 28 news page │ Orphan Drug Designated (FDA news) │
│ Primary Trial Anchor │ Pediatric CD bridging program │ UNIFI Jr (NCT04630028; N=112) │
│ Common Adverse Events │ Not listed on the August 28 │ Nasopharyngitis, headache, abdominal │
│ on Aug 28 FDA page │ pediatric UC news page │ pain, influenza, fever, diarrhea, │
│ │ │ sinusitis, fatigue, and nausea │
└───────────────────────┴───────────────────────────────────┴──────────────────────────────────────┘
The FDA's emphasis on Stelara being the "first non-TNF monoclonal antibody" for both forms of pediatric IBD reflects an important clinical positioning dynamic. For decades, pediatric gastroenterologists treating moderate-to-severe IBD relied almost exclusively on anti-TNF agents (infliximab and adalimumab). Patients experiencing primary non-response, secondary loss of response, or anti-drug antibody formation faced severe therapeutic bottlenecks, often requiring off-label adult biologics or early surgical intervention. Stelara's dual pediatric approvals provide an FDA-approved non-TNF monoclonal-antibody option. Dosing belongs in the posted prescribing information, not in this access note.
(Note: In accordance with clinical publication standards and regulatory guidance, specific dosing regimens, weight-based induction protocols, and reconstitution steps are excluded. Clinicians should consult the FDA-approved prescribing information.)
What Did UNIFI Jr (NCT04630028) Actually Enroll and Demonstrate?
The registrational evidence for pediatric ulcerative colitis relied on a combination of adult extrapolation, pharmacokinetic modeling, and empirical pediatric clinical trial data.
Trial Design and Operational Metrics
The dedicated pediatric UC clinical trial, known as UNIFI Jr (ClinicalTrials.gov Identifier: NCT04630028), was an open-label intravenous (IV) induction study followed by randomized, double-blind subcutaneous (SC) maintenance in pediatric participants with moderately to severely active ulcerative colitis:
- Study Status: COMPLETED.
- Actual Enrollment: 112 participants.
- Start Date: March 17, 2021 (actual).
- Primary Completion Date: May 8, 2025 (actual).
- Study Completion Date: June 5, 2025 (actual).
- Study Phase: Phase 3.
- Primary Design: Evaluation of pharmacokinetic parameters, clinical remission, clinical response, and mucosal healing over a 52-week evaluation period.
┌──────────────────────────────────────────────────────────────────────────────────────────────────┐
│ UNIFI JR (NCT04630028) TRIAL ARCHITECTURE │
├──────────────────────────┬───────────────────────────────────────────────────────────────────────┤
│ Trial Feature │ Verified Protocol Parameter │
├──────────────────────────┼───────────────────────────────────────────────────────────────────────┤
│ Title │ Open-Label IV Induction & Double-Blind SC Maintenance in Pediatric UC │
│ Enrolled Cohort Age │ FDA news page: 112 subjects aged 3 to 17 │
│ CT.gov Eligibility │ NCT04630028 lists ages 2 years to 17 years │
│ Labeled Indication Age │ 2 years of age and older (supported by PK bridging from ped CD) │
│ Baseline Inclusion │ Moderate-to-severe UC (CT.gov: Mayo 6–12; endoscopy subscore ≥2) │
│ Induction Phase │ Open-label intravenous induction │
│ Maintenance Phase │ Randomized, double-blind subcutaneous maintenance through Week 52 │
│ Evaluated Endpoints │ PK profile, clinical remission (Mayo score), endoscopic improvement │
│ FDA Safety Profile │ Nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea │
└──────────────────────────┴───────────────────────────────────────────────────────────────────────┘
Resolving the Age Gap: 3-to-17 Trial Cohort vs. 2-Plus Label
A notable technical distinction in the regulatory package is the difference between the study cohort FDA described, the ClinicalTrials.gov eligibility window, and the approved label:
- FDA's August 28 news page describes a 52-week study in 112 pediatric UC subjects aged 3 to 17 years.
- ClinicalTrials.gov lists NCT04630028 eligibility as ages 2 years to 17 years. That is a protocol window, not a published age-stratified enrollment table.
- The FDA-approved indication covers children aged 2 years and older.
This indication scope was achieved through the FDA's established pediatric extrapolation framework under the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA). Because the underlying disease pathophysiology and ustekinumab exposure-response relationships are consistent across age bands, FDA reviewers bridged adult UC efficacy, UNIFI Jr 3-to-17 empirical data, and pharmacokinetic/safety data from the pediatric Crohn's disease development program (which evaluated patients down to 2 years of age). Access teams should note that this bridging represents formal FDA regulatory science, not unverified label extrapolation.
Why Do DailyMed and Drugs@FDA Still Show Adult-Only UC?
A persistent challenge for market access teams, prior authorization specialists, and specialty pharmacies during the first 30 days following an FDA action is database synchronization lag across federal repositories.
┌──────────────────────────────────────────────────────────────────────────────────────────────────┐
│ FEDERAL REPOSITORY SYNCHRONIZATION AUDIT (2026-08-31) │
├───────────────────────┬───────────────────────────────┬──────────────────────────────────────────┤
│ Federal Database │ Indexed Status / Version │ Operational Impact on Payer Operations │
├───────────────────────┼───────────────────────────────┼──────────────────────────────────────────┤
│ FDA CDER News Page │ Content Current: 08/28/2026 │ Official primary source confirming the │
│ (Primary Authority) │ Approved sBLA for ped UC ≥2y │ pediatric UC approval and orphan status. │
├───────────────────────┼───────────────────────────────┼──────────────────────────────────────────┤
│ DailyMed / openFDA │ Effective Time: 20260721 │ Labeling still lists UC as adult-only │
│ SPL Index │ SetID: c77a9664-e3bb-4023... │ (section 1.4); automated scrapers will │
│ │ Recent Changes: 04/2026 (CD) │ falsely trigger an "off-label" denial. │
├───────────────────────┼───────────────────────────────┼──────────────────────────────────────────┤
│ Drugs@FDA Submissions │ Latest Efficacy Action: │ Supplement for pediatric UC not yet │
│ (BLA 761044) │ SUPPL 20 (20260415, Ped CD) │ indexed as of the August 31 retrieval; │
│ │ │ BLA 125261 latest Labeling AP is 07/2026.│
├───────────────────────┼───────────────────────────────┼──────────────────────────────────────────┤
│ Wezlana Biosimilar │ Effective Time: 20260603 │ CD and UC strictly limited to adults; │
│ SPL (Amgen) │ SetID: a6c23978-09f0-4796... │ pediatric (≥6y) limited to PsO / PsA. │
└───────────────────────┴───────────────────────────────┴──────────────────────────────────────────┘
Navigating Database Latency in Electronic Prior Authorization (ePA)
- The 14-Day SPL Submission Instruction: FDA approval letters typically instruct sponsors to submit content of labeling in Structured Product Labeling (SPL) format as soon as possible and no later than 14 days after the letter. That is a submission clock, not a DailyMed posting SLA; public indexes can lag after the file is transmitted.
- Automated Rejection Risk: Many health plan electronic prior authorization (ePA) modules and third-party utilization management tools dynamically query DailyMed SPL text. As of August 31, 2026, an automated query will return section 1.4 indicating adult UC only.
- Interim Operational Policy: P&T committees and PA review teams must issue operational memorandums directing medical review nurses and adjudicators to accept the August 28 FDA approval notice as proof of labeled indication, preventing inappropriate initial denials for pediatric patients.
Does Wezlana's Interchangeability Designation Extend to Pediatric UC?
The central commercial and clinical question for health plans is whether an interchangeable ustekinumab biosimilar can be utilized for these newly approved pediatric patients. The answer is an unambiguous no.
Understanding Indication-Specific Labeling and Skinny Labels
Under Section 351(k) of the Public Health Service Act (PHSA), a biosimilar sponsor is not required to seek licensure for every condition of use approved for the reference biological product. Furthermore, when an originator obtains a new indication protected by orphan drug exclusivity or new clinical study exclusivity, biosimilar labels cannot automatically carve in that indication until statutory protections expire or supplemental 351(k) applications are reviewed and approved.
┌──────────────────────────────────────────────────────────────────────────────────────────────────┐
│ USTEKINUMAB ORIGINATOR VS. INTERCHANGEABLE BIOSIMILAR INDICATION MATRIX │
├───────────────────────────────────────┬─────────────────────────────┬────────────────────────────┤
│ Approved Labeled Indication │ Stelara (Originator BLA) │ Wezlana (Biosimilar auub) │
├───────────────────────────────────────┼─────────────────────────────┼────────────────────────────┤
│ Plaque Psoriasis (Adults) │ Labeled (Subcutaneous) │ Labeled (Interchangeable) │
│ Plaque Psoriasis (Pediatric ≥6 years) │ Labeled (Subcutaneous) │ Labeled (Interchangeable) │
│ Psoriatic Arthritis (Adults) │ Labeled (Subcutaneous) │ Labeled (Interchangeable) │
│ Psoriatic Arthritis (Pediatric ≥6 yrs)│ Labeled (Subcutaneous) │ Labeled (Interchangeable) │
│ Crohn's Disease (Adults) │ Labeled (IV Induction / SC) │ Labeled (Interchangeable) │
│ Crohn's Disease (Pediatric ≥2 years) │ Labeled (Approved 04/2026) │ NOT LABELED (Adults Only) │
│ Ulcerative Colitis (Adults) │ Labeled (IV Induction / SC) │ Labeled (Interchangeable) │
│ Ulcerative Colitis (Pediatric ≥2 yrs) │ Labeled (Approved 08/2026) │ NOT LABELED (Adults Only) │
└───────────────────────────────────────┴─────────────────────────────┴────────────────────────────┘
Purple Book Rules and State Pharmacy Substitution Laws
The FDA's Purple Book: Database of Licensed Biological Products lists Wezlana (ustekinumab-auub) as interchangeable with Stelara. However, interchangeability is governed by two strict regulatory boundaries:
- Presentation Equivalence: As mapped in our analysis of interchangeability by presentation, interchangeability applies only to matched delivery presentations (e.g., prefilled syringe to prefilled syringe).
- Indication Scope and State Pharmacy Acts: Under typical state pharmacy practice acts, a pharmacist may substitute an interchangeable biologic without prescriber intervention only when the substituted product is FDA-approved for the condition being treated. Dispensing Wezlana for a pediatric patient with ulcerative colitis is off-label relative to the live biosimilar SPL and is outside automatic substitution.
How Health Plans Must Structure Pediatric Ustekinumab Step Therapy
For commercial payers, Medicare Advantage organizations, and state Medicaid fee-for-service / managed care programs, managing ustekinumab utilization management (UM) criteria requires immediate bifurcation based on patient age and diagnosis.
┌──────────────────────────────────────────────────────────────────────────────────────────────────┐
│ PAYER PRIOR AUTHORIZATION & STEP THERAPY DECISION MATRIX │
├───────────────────────┬───────────────────┬──────────────────────────────────────────────────────┤
│ Patient Cohort │ Primary Diagnosis │ Required Formulary / Step Therapy Rule │
├───────────────────────┼───────────────────┼──────────────────────────────────────────────────────┤
│ Adult (Age ≥18) │ Crohn's Disease │ Standard biosimilar cascade; step through preferred │
│ │ or Ulcerative Col │ interchangeable ustekinumab biosimilar (e.g. Wezlana)│
├───────────────────────┼───────────────────┼──────────────────────────────────────────────────────┤
│ Adult (Age ≥18) │ Plaque Psoriasis │ Standard biosimilar cascade; preferred biosimilars │
│ │ or PsA │ mandated prior to originator Stelara access. │
├───────────────────────┼───────────────────┼──────────────────────────────────────────────────────┤
│ Pediatric (Ages 6–17) │ Plaque Psoriasis │ Biosimilar substitution permissible; Wezlana labeled │
│ │ or PsA │ and interchangeable for pediatric PsO/PsA (≥6 yrs). │
├───────────────────────┼───────────────────┼──────────────────────────────────────────────────────┤
│ Pediatric (Ages 2–17) │ Crohn's Disease │ Carve-out warranted: originator Stelara labeled; │
│ │ │ biosimilar IBD SPL remains adult-only. │
├───────────────────────┼───────────────────┼──────────────────────────────────────────────────────┤
│ Pediatric (Ages 2–17) │ Ulcerative Colitis│ Carve-out warranted: originator Stelara labeled; │
│ │ │ biosimilar IBD SPL remains adult-only. │
└───────────────────────┴───────────────────┴──────────────────────────────────────────────────────┘
Key Prior Authorization Documentation Elements for Pediatric UC
When submitting PA documentation for a pediatric patient aged 2 to 17 years with ulcerative colitis, access teams should include:
- Confirmed Diagnosis: Moderately to severely active ulcerative colitis documented by endoscopy or clinical score (e.g., Pediatric Ulcerative Colitis Activity Index / PUCAI).
- Patient Age: Verified birthdate establishing age ≥2 years.
- Prior Therapy History: Documented inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators (e.g., azathioprine, 6-mercaptopurine), or anti-TNF therapy (e.g., infliximab).
- Exclusion of Biosimilar Step Mandate: Explicit notation that available ustekinumab biosimilars carry adult-only IBD labeling, establishing medical necessity for originator Stelara.
Market Access, IRA Deselection, and Portfolio Implications
The pediatric ulcerative colitis sBLA approval intersects with broader commercial dynamics governing the ustekinumab franchise:
1. Medicare Inflation Reduction Act (IRA) Deselection Clock
Under the Inflation Reduction Act of 2022, Stelara was selected as one of the initial 10 drugs subject to Medicare Maximum Fair Price (MFP) negotiation for Initial Price Applicability Year 2026. However, as detailed in our analysis of the Stelara IRA deselection clock, the entry of bona fide commercial biosimilar competition (including Wezlana and Pyzchiva) led CMS to deselect Stelara from MFP effectuation effective January 1, 2027. The pediatric label expansion does not alter this statutory deselection, as pediatric IBD volume is predominantly commercial and Medicaid rather than Medicare Part D.
2. Medicaid EPSDT and Coverage Mandates
Under Medicaid's Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) provisions (42 U.S.C. § 1396d(r)), state Medicaid programs are legally required to provide comprehensive coverage for all medically necessary, FDA-approved services and pharmaceuticals for beneficiaries under age 21. Because Stelara is now FDA-approved for pediatric UC, state Medicaid Preferred Drug Lists (PDLs) that attempt to restrict access to off-label adult biosimilars face immediate administrative and legal non-compliance risks.
3. Updates to Existing PharmaDossier Reference Guides
This regulatory approval directly updates several core analyses across our publication:
- In our Stelara coverage guide, the short-answer table and indication matrix (which previously listed ulcerative colitis as adult-only) will be updated to reflect the August 28 pediatric sBLA once final SPL posts.
- In our overview of the 2026 IBD access landscape, the adult biosimilar cascade remains intact, but the pediatric labeled-biologic map now includes Stelara as the first FDA-approved non-TNF monoclonal antibody for both Crohn's disease and ulcerative colitis.
- For product-level formulation, excipient, and device comparisons across the ustekinumab landscape, see Stelara biosimilars compared.
Frequently Asked Questions
Did FDA approve Stelara for ulcerative colitis in children 2 years and older?
Yes. On August 28, 2026, FDA approved a supplemental BLA for Stelara (ustekinumab) for the treatment of moderately to severely active ulcerative colitis in pediatric patients aged 2 years and older. The approval includes Orphan Drug Designation for this indication.
Can a pharmacy auto-substitute Wezlana for a pediatric UC Stelara prescription?
No. While Wezlana (ustekinumab-auub) is an FDA-designated interchangeable biosimilar to Stelara, its approved labeling for inflammatory bowel disease (Crohn's disease and ulcerative colitis) is strictly restricted to adult patients. State pharmacy practice acts prohibit pharmacists from substituting an interchangeable biologic for an indication that the biosimilar is not FDA-approved to treat.
Is the current DailyMed Stelara SPL the August 28 pediatric UC label?
No. As of August 31, 2026, the live SPL for Stelara on DailyMed and openFDA (setid c77a9664-e3bb-4023-b400-127aa53bca2b, effective_time 20260721) reflects the previous labeling update from July 2026 and still lists ulcerative colitis as adult-only. Sponsors have up to 14 days following approval to submit updated SPL. Payers and PA review teams should rely on the FDA approval notice until the new SPL is indexed.
Was the pediatric UC study the same 112-patient UNIFI Jr trial listed on ClinicalTrials.gov?
Yes. The dedicated pediatric UC clinical trial listed on ClinicalTrials.gov is UNIFI Jr (NCT04630028), a Phase 3 study with actual enrollment of 112. FDA's August 28 news page describes that 52-week study as 112 pediatric UC subjects aged 3 to 17 years; ClinicalTrials.gov lists eligibility as ages 2 to 17. FDA reviewers also used adult UC studies and pediatric Crohn's disease pharmacokinetic/safety data to support the labeled indication for patients aged 2 years and older.
Sources
- U.S. Food and Drug Administration (CDER): FDA Approves Stelara for Pediatric Ulcerative Colitis. News & Events – Human Drugs. Approved August 28, 2026; content current August 28, 2026. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-stelara-pediatric-ulcerative-colitis
- U.S. Food and Drug Administration (CDER): What's New Related to Drugs – 2026. CDER Drug and Biologic Approvals Index. Retrieved August 31, 2026. https://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs
- U.S. National Library of Medicine / DailyMed: STELARA (ustekinumab injection) Structured Product Labeling. SetID:
c77a9664-e3bb-4023-b400-127aa53bca2b, Effective Time: 20260721. Retrieved August 31, 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c77a9664-e3bb-4023-b400-127aa53bca2b - U.S. Food and Drug Administration / openFDA: WEZLANA (ustekinumab-auub) Drug Label API. SetID:
a6c23978-09f0-4796-88f7-d0ce7e3ed04e, Effective Time: 20260603. Retrieved August 31, 2026. https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22WEZLANA%22 - U.S. Food and Drug Administration / Drugs@FDA: Application Tracking – BLA 761044 / BLA 125261 (STELARA). Latest indexed Efficacy Action: Supplement 20 (pediatric Crohn's disease approval, dated 2026-04-15) as retrieved August 31, 2026. https://api.fda.gov/drug/drugsfda.json?search=openfda.brand_name:%22STELARA%22
- ClinicalTrials.gov / National Institutes of Health: A Study of the Safety, Efficacy, and Pharmacokinetics of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UNIFI Jr). Identifier: NCT04630028. Phase 3, Completed, Actual Enrollment: 112. Retrieved August 31, 2026. https://clinicaltrials.gov/study/NCT04630028
- U.S. Food and Drug Administration: Purple Book: Database of Licensed Biological Products. Reference Product Exclusivity and Biosimilar Interchangeability Listings for Ustekinumab. https://purplebooksearch.fda.gov/
