Stelara Biosimilar: Cheaper Ustekinumab Alternatives in 2026

Stelara (ustekinumab) has for years ranked among the highest-grossing biologic drugs in the world, generating billions of dollars in annual U.S. sales for Johnson & Johnson’s Janssen unit. A Stelara biosimilar is a lower-cost, FDA-approved alternative for patients treating conditions like plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. With key patents now expired and a wave of manufacturers cleared by the FDA in 2024 and 2025, biosimilar competition is finally reshaping the cost landscape for this widely prescribed biologic.

This guide explains what the approved ustekinumab biosimilars are, how much they may save, how interchangeability works, and — most importantly — why any decision to start or switch this medication belongs with your prescriber and care team, not a website. Drug approvals, prices, and formularies change quickly, so treat every figure here as a starting point to verify with current sources.

What Is Stelara and Why Does It Cost So Much?

Stelara is a monoclonal antibody that targets two signaling proteins, interleukin-12 (IL-12) and interleukin-23 (IL-23), which help drive inflammatory and immune responses. The FDA first approved Stelara in September 2009 for moderate-to-severe plaque psoriasis, and later approvals expanded its use to psoriatic arthritis (2013), Crohn’s disease (2016), and ulcerative colitis (2019). It is given by subcutaneous injection or, for some indications, an initial intravenous dose, typically followed by maintenance dosing every 8 to 12 weeks after a loading phase.

The reported list price for Stelara has run into the tens of thousands of dollars per dose, and annual treatment costs can reach well into five or six figures depending on the indication and dosing schedule. What a given patient actually pays depends heavily on insurance, deductibles, coinsurance, and manufacturer assistance — so list price is rarely the out-of-pocket price. Those steep sticker prices reflect the complexity of manufacturing biologic drugs, the cost of clinical development, and the market exclusivity Janssen maintained through an extensive patent portfolio. To understand the disease side of these conditions, see our medical conditions guide.

Stelara Patent Expiration and the Biosimilar Timeline

Janssen’s patents on Stelara were the subject of intense litigation. The company’s core composition-of-matter patent expired around 2023, but additional patents covering formulation, manufacturing, and specific uses extended protection. Through a series of patent settlements with biosimilar developers, the path to market opened on a staggered schedule beginning in 2025, which is why several products were approved well before they actually launched. Understanding how drug patents and settlements work helps explain why competition was delayed for more than a decade after the first approvals.

Each Stelara biosimilar reached the market only after the FDA evaluated extensive analytical, preclinical, and clinical data demonstrating biosimilarity to the reference product. These approvals were a meaningful milestone for patients who had paid premium prices for years.

FDA-Approved Stelara (Ustekinumab) Biosimilars

As of 2025-2026, the FDA has approved multiple biosimilars to Stelara. Because new products and updates appear regularly, confirm the current, complete list on the FDA’s Biosimilar Product Information page or the Purple Book before making decisions. As of this update, approved ustekinumab biosimilars include:

• Wezlana (ustekinumab-auub) — approved October 2023; the first ustekinumab biosimilar and the first designated interchangeable.
• Selarsdi (ustekinumab-aekn) — approved April 2024.
• Pyzchiva (ustekinumab-ttwe) — approved June 2024.
• Otulfi (ustekinumab-aauz) — approved September 2024.
• Imuldosa (ustekinumab-srlf) — approved October 2024.
• Yesintek (ustekinumab-kfce) — approved November 2024.
• Steqeyma (ustekinumab-stba) — approved December 2024.
• Starjemza (ustekinumab-hmny) — approved May 2025.

These products come from a range of biosimilar developers (companies widely reported in this space include Amgen, Teva/Alvotech, Samsung Bioepis, Fresenius Kabi/Formycon, Accord, Biocon, and Celltrion, among others; verify the current sponsor for any specific product). Each biosimilar had to demonstrate that it is highly similar to the reference product, with no clinically meaningful differences in safety, purity, or potency. For the fundamentals, see our explainer on what biosimilars are.

The FDA’s approval framework for biosimilars was established under the Biologics Price Competition and Innovation Act (BPCIA) of 2009. Manufacturers submit data from analytical (structural and functional) studies, and typically comparative clinical data, to show biosimilarity. It is a rigorous, evidence-based pathway rather than a shortcut.

Interchangeability: A Separate FDA Designation

“Biosimilar” and “interchangeable” are not the same thing. An interchangeability designation means a pharmacist may, subject to state law, substitute the product for the reference drug without contacting the prescriber — similar to how generic small-molecule drugs are substituted. Wezlana was the first ustekinumab biosimilar to receive this designation, and other products have since sought or obtained it. The FDA has also signaled it may move away from treating interchangeability as a separate, higher bar, so the practical distinction is evolving. Check the current status of any specific product, because interchangeability affects whether a switch happens at the pharmacy counter or requires a new prescription.

How Much Could a Stelara Biosimilar Save You?

Historical data from other biosimilar launches suggests patients and the healthcare system can see meaningful savings, though the size and timing vary. When biosimilar Humira (adalimumab) alternatives entered the market, discounts of roughly 30 to 80 percent off list appeared depending on the payer and distribution channel — but real patient savings lagged, in part because of how rebates and formularies work. Similar dynamics are unfolding for ustekinumab.

The Congressional Budget Office has estimated that biosimilar competition across biologic categories could save the U.S. healthcare system tens of billions of dollars over a decade. For an individual, switching to a Stelara biosimilar could lower out-of-pocket costs, especially for those with high-deductible plans or coinsurance — but your actual savings depend on your specific plan.

Insurance coverage and formulary placement drive real-world costs. A key player is the pharmacy benefit manager; understanding what a PBM is helps explain why the “cheaper” drug is not always the one your plan prefers. Ask your insurer and pharmacist how each option affects your cost-sharing, and note that biologics are often covered under a specialty tier or the medical benefit rather than a standard pharmacy copay. Discount tools like GoodRx are more useful for retail small-molecule drugs than for specialty biologics, so lean on your plan and any manufacturer assistance program first.

Safety and Monitoring: Why This Is Prescriber-Directed

Ustekinumab, whether brand or biosimilar, is an immunosuppressant. That has important safety implications that make it a specialist-directed therapy — usually managed by a dermatologist, rheumatologist, or gastroenterologist — and not something to self-manage:

• Serious infections. Because the drug suppresses part of the immune system, it can raise the risk of serious bacterial, fungal, and viral infections. Prescribers screen for and monitor infections during treatment.
• Tuberculosis screening. The labeling calls for evaluating patients for latent and active TB before starting ustekinumab and monitoring during therapy; latent TB is generally treated before the biologic begins.
• Vaccinations. Live vaccines are generally avoided during treatment, and your team may want to update vaccinations beforehand.
• Other precautions. Labeling notes rare risks such as posterior reversible encephalopathy syndrome (PRES) and hypersensitivity reactions. Report new or worsening symptoms promptly.

The FDA requires every approved biosimilar to show no clinically meaningful differences from the reference product in safety, effectiveness, and immunogenicity, and post-market surveillance continues after approval. Published Phase III data for ustekinumab biosimilars have shown comparable response rates and adverse-event profiles versus the reference product. None of this replaces an individualized conversation with your clinician about your history and risks.

Switching from Stelara to a Biosimilar

Patients on Stelara often ask whether switching is safe. Switching studies — frequently built into biosimilar development programs — evaluate whether transitioning from the reference product to the biosimilar changes efficacy or safety. Across biologic categories, these studies have generally not shown increased adverse events, reduced efficacy, or greater immunogenicity from a single switch. Professional societies including the American College of Rheumatology and the American Gastroenterological Association have published positions supportive of biosimilar use in appropriate settings.

Even so, any switch should be a shared decision with your prescriber. Disease stability, prior treatment history, device/injection differences, and insurance coverage all matter. Do not change, skip, or self-substitute doses on your own.

How Biosimilars Differ from Generics

Unlike small-molecule generics, biosimilars are not identical copies of their reference product. Biologics are made in living cells, which introduces natural, tightly controlled variability — the same is true for different batches of the original drug. That is why biosimilars use a distinct regulatory pathway rather than the Abbreviated New Drug Application (ANDA) process used for conventional generics. For a fuller comparison, see biosimilar vs generic, and put it in context with our broader healthcare costs guide.

Frequently Asked Questions

When will Stelara biosimilars be widely available?

Multiple ustekinumab biosimilars have been FDA-approved, with launches phased in through 2025 and 2026 under patent-settlement timelines. Real-world availability depends on those settlements, manufacturing, and payer formulary decisions, so check with your pharmacy and plan for current options.

Are Stelara biosimilars as effective as the original?

The FDA requires biosimilars to show no clinically meaningful differences from the reference product. Clinical trials for ustekinumab biosimilars have shown comparable efficacy and safety. Discuss what this means for your specific condition with your prescriber.

Will my insurance cover a Stelara biosimilar?

Coverage depends on your plan and the product’s formulary placement. Many insurers now prefer a biosimilar, and some use step therapy. Because biologics are often specialty-tier or covered under the medical benefit, contact your insurer for exact cost-sharing.

Can my pharmacist switch me to a Stelara biosimilar automatically?

Only if the specific product has an FDA interchangeability designation and your state’s pharmacy laws allow substitution. Wezlana was the first interchangeable ustekinumab; others are following. Without interchangeability, your prescriber must write for the specific product. Verify current status.

Is a biosimilar a “fake” or lower-quality version of Stelara?

No. A biosimilar is a distinct FDA-approved biologic held to rigorous standards of similarity to the reference product. It is manufactured, reviewed, and monitored like any other biologic.

What This Means for Your Treatment Costs

The arrival of Stelara biosimilar competition is a genuine opportunity to reduce spending on one of the most expensive biologic therapies. Meaningful discounts are realistic based on precedent from other biosimilar categories, but your out-of-pocket result depends on coverage, formularies, and assistance programs — and clinical suitability always comes first. Bring the question to your prescriber and insurer, and follow the healthcare policy landscape, which shapes access to affordable biologics.

Sources

• U.S. Food and Drug Administration — Biosimilar Product Information and the Purple Book (approved ustekinumab biosimilars and interchangeability status).
• U.S. Food and Drug Administration — “Biosimilar and Interchangeable Biologics: More Treatment Choices” (consumer overview).
• Stelara (ustekinumab) FDA prescribing information / DailyMed (indications, tuberculosis screening, serious-infection warnings).
• Congressional Budget Office — analyses of biosimilar and drug-price competition savings.
• American College of Rheumatology and American Gastroenterological Association — position statements on biosimilar use and switching.