Updated: January 28, 2026

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

Author

Peter Daggett

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Current Availability Status
Understanding the Ustekinumab Biosimilar Formulary Landscape
Interchangeability: What It Means for Your Practice
Managing Prior Authorization for Pyzchiva
Patient Access Resources for Pyzchiva

A provider-focused guide to Pyzchiva availability, biosimilar formulary navigation, prior authorization, and patient support resources in 2026.

Pyzchiva (ustekinumab-ttwe) launched commercially in February 2025, entering one of the most competitive biosimilar markets in recent US history. For dermatologists, rheumatologists, gastroenterologists, and other prescribers, the biosimilar ustekinumab landscape is evolving quickly — and navigating it on behalf of patients requires staying current on formulary decisions, payer contracts, and the interchangeability landscape.

This guide is intended for healthcare providers. For patient-facing information, see our patient shortage update.

Current Availability Status

As of 2026, Pyzchiva is not on the FDA official drug shortage list. There is no manufacturing disruption reported. The drug is commercially available in the United States through Sandoz's specialty pharmacy distribution network. Pyzchiva is available in:

45 mg/0.5 mL prefilled syringe (subcutaneous)
90 mg/mL prefilled syringe (subcutaneous)
45 mg/0.5 mL single-dose vial (subcutaneous)
130 mg/26 mL (5 mg/mL) single-dose vial for IV infusion (for IBD induction)
45 mg and 90 mg autoinjector devices

Understanding the Ustekinumab Biosimilar Formulary Landscape

As of 2025-2026, seven ustekinumab biosimilars have received FDA approval, all with the same indications as Stelara. This has created a highly fragmented formulary environment where access to any specific biosimilar depends entirely on the patient's payer:

Wezlana (ustekinumab-auub, Amgen) launched January 2025 — available exclusively through Optum Rx
Pyzchiva (ustekinumab-ttwe, Samsung Bioepis/Sandoz) launched February 2025
Selarsdi (ustekinumab-aekn, Alvotech/Teva) launched February 2025
Yesintek (ustekinumab-kfce, Biocon Biologics) launched February 2025
Otulfi, Imuldosa, Steqeyma, Starjemza — approved and entering market in 2025-2026

For prescribers, the key takeaway is that the formulary-preferred biosimilar varies by payer. Before routing a prescription to a specialty pharmacy, verify which ustekinumab biosimilar is preferred by your patient's plan. This will minimize delays and reduce PA burden.

Interchangeability: What It Means for Your Practice

Pyzchiva has received a provisional interchangeability designation from the FDA — meaning it can be substituted for Stelara at the pharmacy level without prescriber intervention, subject to state law. Full interchangeability designation for Pyzchiva is pending the expiration of Wezlana's 1-year exclusivity as the first interchangeable ustekinumab biosimilar.

Practically, this means:

Pharmacists in many states may substitute Pyzchiva for Stelara prescriptions without contacting you
Patients currently on Stelara may be switched to Pyzchiva by the pharmacy or their insurer without a new prescription
Counsel patients proactively that biosimilar substitution may occur and that all ustekinumab products are clinically equivalent in terms of safety and efficacy

Managing Prior Authorization for Pyzchiva

Prior authorization is required by virtually all commercial and Medicare Part D plans for ustekinumab products. For Pyzchiva specifically:

Initiate the PA at the time of prescribing to minimize delays for your patient
Check the patient's formulary before submitting the PA — if their plan prefers a different biosimilar, the PA may be denied outright
Sandoz can assist with PA support — contact the Sandoz provider line or visit pyzchiva.com/pro for resources
If the PA is denied, consider appealing with clinical documentation, or discuss with the patient whether switching to the preferred biosimilar is appropriate

Patient Access Resources for Pyzchiva

Sandoz provides the following support programs for Pyzchiva patients:

Co-pay assistance: Commercially insured patients may pay as little as $0 per treatment. Register at pyzchiva.com or call 1-855-726-3698.
Patient assistance program: For uninsured or underinsured patients who meet income criteria.
PA support: Sandoz can assist providers in navigating prior authorization with individual payers.

medfinder also offers a provider tool to help locate which pharmacies near your patients have Pyzchiva in stock. Visit medfinder for providers to learn more.

Frequently Asked Questions

Yes. Pyzchiva is approved for pediatric patients 6 years of age and older with moderate-to-severe plaque psoriasis and active psoriatic arthritis. For Crohn's disease and ulcerative colitis, safety and efficacy have not been established in pediatric patients, and Pyzchiva is approved only for adults 18 and older for those indications.

You can prescribe Pyzchiva, but if your patient's plan prefers another biosimilar, the prior authorization may be denied or require additional documentation. Check your patient's formulary before submitting the PA. If access to Pyzchiva specifically is important for clinical reasons, document your medical justification for a PA appeal. Otherwise, prescribing the formulary-preferred biosimilar will typically result in faster access for your patient.

For adult patients with moderately to severely active Crohn's disease, the induction dose is a single IV infusion based on body weight (260 mg for patients ≤55 kg, 390 mg for 55–85 kg, 520 mg for >85 kg). The maintenance dose is 90 mg subcutaneous every 8 weeks beginning 8 weeks after the initial IV dose.

No. Pyzchiva does not have a Risk Evaluation and Mitigation Strategy (REMS) program. However, prescribers should counsel patients on the risks of serious infections, malignancy, PRES, and other serious adverse events before initiating therapy. Patients should be screened for latent tuberculosis before starting Pyzchiva.

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