Stelara Shortage: What Providers and Prescribers Need to Know in 2026

For dermatologists, rheumatologists, gastroenterologists, and other providers managing patients on ustekinumab, 2026 presents a landscape that looks quite different from even 12 months ago. Brand-name Stelara — historically one of the world's highest-grossing drugs at $10.4 billion in 2024 — is being systematically displaced from insurance formularies by a wave of biosimilars. While this transition ultimately benefits patients through lower costs, the transition period is generating significant administrative burden and access disruption at the clinic level.

This guide provides a current clinical picture of the ustekinumab market in 2026 and actionable steps your practice can take to reduce patient access disruptions.

Current Availability Status: No FDA Shortage, But Significant Access Disruption

As of 2026, Stelara (ustekinumab) is not listed on the FDA's drug shortage database. Supply disruption at the manufacturing level is not the issue. The access problems your patients are experiencing are driven by:

Rapid formulary transitions from brand Stelara to preferred biosimilar products

Exclusive pharmacy distribution for certain biosimilars (Wezlana only through Optum, for example)

Prior authorization and step therapy requirements that vary by payer and plan

Patient and prescriber confusion about which biosimilar is covered under a patient's specific plan

The Biosimilar Landscape: Eight Approved Products in 2026

Eight ustekinumab biosimilars are FDA-approved and commercially available in 2026. All share the same indications as reference Stelara (plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis). Seven of the eight carry FDA interchangeability designation, permitting pharmacist substitution without prescriber intervention (subject to state law).

Wezlana (ustekinumab-auub): Amgen; first to market Jan 2025; interchangeable; exclusive to Optum Specialty Pharmacy

Pyzchiva (ustekinumab-ttwe): Samsung Bioepis/Sandoz; WAC ~80% below Stelara; interchangeable

Yesintek (ustekinumab-kfce): Biocon Biologics; WAC ~$3,000 (approximately 90% below Stelara); interchangeable

Selarsdi (ustekinumab-aekn): Teva/Alvotech; WAC ~85% below Stelara; interchangeable

Steqeyma (ustekinumab-stba): Celltrion; approved Dec 2024, launched Feb 2025; interchangeable

Otulfi (ustekinumab-aauz): Fresenius Kabi; approved Sep 2024; interchangeable

Imuldosa (ustekinumab-srlf): Accord BioPharma; approved Oct 2024; NOT interchangeable — requires prescriber to specifically order by name

Starjemza (ustekinumab-hmny): Bio-Thera Solutions; approved May 2025

Clinical Equivalency: What the Evidence Shows

FDA-approved ustekinumab biosimilars have demonstrated pharmacokinetic equivalence and comparable clinical efficacy and safety to brand Stelara in clinical trials. For example, Steqeyma's phase 3 confirmatory study demonstrated a mean PASI improvement of 77.93% at week 12 versus 75.89% for reference Stelara. All approved biosimilars underwent rigorous totality-of-evidence evaluations. There is no established clinical rationale to prefer brand Stelara over an interchangeable biosimilar.

Prior Authorization Strategies for 2026

Prior authorization remains a near-universal requirement for ustekinumab, whether brand or biosimilar. Steps to streamline PA in your practice:

Verify the patient's formulary before prescribing — confirm which ustekinumab product is covered under their specific plan and which specialty pharmacy network they are required to use.

Write biosimilar prescriptions by specific product name — since Imuldosa is not interchangeable, it must be explicitly ordered. For interchangeable biosimilars, you may still wish to name the preferred product to avoid pharmacy-level substitution to a version not covered by the patient's plan.

Document clinical necessity thoroughly in the PA request — include disease severity, prior therapy failures, and any contraindications to alternative treatments.

Submit PAs proactively — ideally before the patient's current supply runs out, particularly when their insurer has announced a formulary change.

When to Consider Alternatives to Ustekinumab

In some cases, a different biologic may be clinically appropriate or may face fewer access barriers for a specific patient:

For psoriasis/PsA: Skyrizi (risankizumab) or Tremfya (guselkumab) may be preferred by certain plans, and both have strong efficacy data.

For Crohn's/UC: Skyrizi (risankizumab) or Entyvio (vedolizumab) are commonly used alternatives with favorable safety profiles.

If a patient has contraindications to biologics, oral agents such as Otezla (apremilast) or JAK inhibitors like Rinvoq (upadacitinib) may be appropriate.

How medfinder Can Help Your Patients Access Ustekinumab

When patients are struggling to locate their covered ustekinumab product at a specialty pharmacy, medfinder for providers can help. medfinder contacts specialty pharmacies on behalf of your patient to find which ones can fill their prescription. You can direct patients to medfinder.com to start a search by medication, dosage, and location.

See also: How to Help Your Patients Find Stelara in Stock: A Provider's Guide