Stelara Biosimilar List 2026: All 8 FDA-Approved Ustekinumab Biosimilars

The Short Answer

The FDA has approved eight biosimilars to Stelara (ustekinumab), Johnson & Johnson’s immunology blockbuster. In order of approval they are Wezlana, Selarsdi, Pyzchiva, Otulfi, Imuldosa, Yesintek, Steqeyma and Starjemza. All eight were on the US market by November 2025, and most carry an interchangeable designation, which lets a pharmacist substitute them for Stelara where state law allows.

The class moved faster than Humira did. Stelara biosimilars launched at discounts of 80% to 90% off the reference list price, large pharmacy benefit managers switched their formularies within months, and biosimilars held 42% of the ustekinumab market by the first quarter of 2026, according to Samsung Bioepis’ quarterly market report.

Every FDA-Approved Stelara Biosimilar

Approval dates follow the FDA’s biosimilar product list; launch dates follow Samsung Bioepis’ July 2026 US biosimilar market report. Interchangeability is based on FDA actions and company announcements.

Several of these products are also sold as unbranded versions or under pharmacy benefit managers’ private labels, so a patient may receive the same molecule under a different name. Wezlana, for example, launched exclusively through Optum’s private-label company, Nuvaila.

What Stelara Is and Why It Matters

Stelara (ustekinumab) is an antibody that blocks two immune-signaling proteins, interleukin-12 and interleukin-23. It is approved for plaque psoriasis and psoriatic arthritis in adults and children, and for Crohn’s disease and ulcerative colitis in adults, given as an intravenous infusion to start treatment in inflammatory bowel disease and as subcutaneous injections after that.

It was one of Johnson & Johnson’s largest products, which is why its loss of exclusivity was watched so closely. Stelara’s worldwide sales fell 41.3% to $6.08 billion in 2025 as biosimilars launched, and US sales were about $3.8 billion for the year, according to J&J’s annual report. In the fourth quarter of 2025, US Stelara sales were down 54.9% on a year earlier.

Dose Forms and Presentations

Stelara comes in four presentations: 45 mg/0.5 mL and 90 mg/mL prefilled syringes for subcutaneous injection, a 45 mg/0.5 mL single-dose vial for subcutaneous use, mainly for children, and a 130 mg/26 mL vial for the intravenous infusion that starts treatment in Crohn’s disease and ulcerative colitis. A biosimilar that covers all four can replace Stelara across every indication and patient group.

Most launched with the syringes and the intravenous vial and have filled the gaps since. Celltrion added the pediatric 45 mg vial for Steqeyma in June 2025, so that it matches every Stelara dosage form and strength; Fresenius Kabi did the same for Otulfi in January 2026; and in August 2026 Biocon received FDA approval for Yesintek in a single-dose prefilled autoinjector, in 45 mg and 90 mg strengths, a presentation Stelara itself does not offer. Competition in a crowded class increasingly runs through these details of convenience and coverage.

How the Market Opened

Although the first biosimilar was approved in October 2023, US launches were governed by patent settlements with Johnson & Johnson. Amgen’s settlement, reached in May 2023, allowed Wezlana to launch no later than January 1, 2025, and the other developers settled for entry dates in the first months of 2025.

The result was a compressed launch wave. Wezlana arrived in January 2025; Selarsdi, Pyzchiva and Yesintek in February; Otulfi and Steqeyma in March. Imuldosa followed in August and Starjemza, the last approved, in November. Within a single year the reference product went from no competition to eight biosimilar competitors, many of them interchangeable.

Interchangeability in the Stelara Class

An interchangeable biosimilar can be substituted for the reference product at the pharmacy without the prescriber’s intervention, subject to state law. The first biosimilar to win that designation for a reference product receives a period of exclusivity during which later products can only receive a provisional determination.

In the Stelara class, Wezlana held that first-interchangeable exclusivity until April 30, 2025. After it expired, Selarsdi’s interchangeable designation took effect, Fresenius Kabi announced interchangeability for Otulfi in May 2025, and Celltrion announced full interchangeability for Steqeyma across all of Stelara’s indications in June 2025. Starjemza was approved as interchangeable in May 2025, and the FDA’s review of Yesintek covers its interchangeable presentations. Pyzchiva received a provisional interchangeability determination when it was approved in June 2024. Imuldosa has not been designated interchangeable.

In practice, interchangeability matters less than it once did. Most ustekinumab is dispensed through pharmacy benefits, where formulary decisions by pharmacy benefit managers decide which product a patient receives.

Which Product Will a Patient Receive?

With eight biosimilars on the market, the product a patient receives is rarely chosen by the patient. Three things decide it.

1. The health plan’s formulary. Pharmacy benefit managers decide which ustekinumab products are preferred, and often prefer their own private-label versions. A plan may cover only one or two of the eight.
2. Interchangeability and state law. Where a biosimilar is designated interchangeable, a pharmacist can substitute it for Stelara without a new prescription, subject to state substitution rules and notification requirements.
3. The setting of care. The first intravenous dose for Crohn’s disease and ulcerative colitis is usually given in an infusion center or hospital, which buys under different arrangements from retail and specialty pharmacies.

For patients already stable on Stelara, any switch is a decision for the treating physician and the plan. This article describes the market and is not medical advice.

Prices, Private Labels and Formularies

Stelara’s list price was $25,497.12 for a 90 mg dose every eight weeks when the biosimilars launched. According to Managed Healthcare Executive, Selarsdi launched about 85% below that price, Pyzchiva about 80% below, and Biocon’s Yesintek at a wholesale acquisition cost of about $3,000, roughly 90% below, making it the lowest-priced at launch.

The bigger change was in who controls the product. All three large pharmacy benefit managers now run private-label biosimilar businesses:

• Optum Rx launched Wezlana exclusively through its Nuvaila private label in both high and low list-price versions, and from July 1, 2025 dropped Stelara from its main commercial formularies in favor of those versions.
• CVS Caremark lists Pyzchiva from its own Cordavis subsidiary alongside Sandoz’s Pyzchiva and Biocon’s Yesintek, at list prices 86% to 90% below Stelara’s, according to Drug Channels.
• Express Scripts offers a version through its Quallent private label, which Drug Channels found listed at only a 46% discount to Stelara, far less than the 90% first announced.

For patients and employers, the effect has been rapid switching. For biosimilar developers, it means the main customer is now the pharmacy benefit manager, and a private-label supply agreement can matter more than being first or interchangeable.

Stelara and Medicare Price Negotiation

Stelara was one of the first ten drugs selected for Medicare price negotiation under the Inflation Reduction Act. CMS set its negotiated price, the maximum fair price, at $4,695 for a 30-day supply, 66% below its 2023 list price of $13,836, effective January 1, 2026. By then, however, the biosimilars had already launched.

DLA Piper’s March 2026 analysis found that the list prices of all the ustekinumab biosimilars were still $3,400 to $6,000 lower than Stelara at its negotiated price, and that Medicare patients’ coinsurance on the biosimilars was about $800 to $1,300 lower. Because biosimilars are now on the market, CMS announced in November 2025 that Stelara, together with Entresto and Xarelto, would be removed from the selected drug list from January 1, 2027, so its government-set price will apply for one year only.

Stelara is therefore the first biologic to show how the two policies interact: competition from biosimilars achieved larger price reductions than negotiation, and the arrival of biosimilars ended the negotiated price. For developers of future biosimilars, whether a reference product has been selected for negotiation, and when, is now part of the market assessment.

Market Share and Stelara’s Decline

Samsung Bioepis’ July 2026 report found that biosimilars held 42% of the US ustekinumab market in the first quarter of 2026, up 15% on the previous quarter, and that ustekinumab biosimilars are gaining share significantly faster than adalimumab biosimilars did. The same report counted 96 FDA-approved biosimilars across 21 molecules as of June 2026.

Johnson & Johnson reported US Stelara sales of about $3.8 billion in fiscal 2025, and in the first quarter of 2026 worldwide sales fell about 60% from a year earlier to $656 million, for a drug that topped $10 billion in annual sales at its peak. The company expects continued biosimilar launches around the world to keep reducing Stelara sales. Not all of that loss goes to the biosimilars: J&J’s chief financial officer, Joseph Wolk, said that many patients have moved to other treatments such as Tremfya, J&J’s own IL-23 inhibitor, rather than switching to a biosimilar. For the wider market, Stelara is the clearest evidence yet that a crowded, interchangeable biosimilar class can take substantial share within the first year.

Timeline of the Stelara Biosimilar Class

Stelara Biosimilars in Europe

Europe moved first on approvals. Uzpruvo, developed by Alvotech and marketed by STADA, became the first ustekinumab biosimilar authorized in the EU in January 2024, and the European Commission had approved seven ustekinumab biosimilars by the end of September 2024, including Pyzchiva, Wezenla (Amgen’s European brand), Steqeyma, Eksunbi, Fymskina and Otulfi. Commercial entry followed the expiry of Stelara’s supplementary protection certificate in July 2024, and further products, including Accord’s Absimky and Imuldosa, received positive opinions later in 2024.

Because European prices are negotiated country by country, often through tenders, the European launch looked different from the US one: less about rebates and private labels, more about national procurement. Our biosimilar news tracker follows approvals and launches across both markets.

Who Develops Them

The Stelara class is a map of where biosimilar development now happens. Of the eight US products, two come from Korean developers (Samsung Bioepis and Celltrion) and a third, Imuldosa, from Korea’s Dong-A ST; one from India’s Biocon; one from Iceland’s Alvotech; one from Germany’s Formycon; one from Amgen in the US; and Starjemza from Bio-Thera Solutions, based in Guangzhou, China.

Most reach US patients through a commercial partner rather than on their own: Teva sells Selarsdi, Sandoz sells Pyzchiva, Fresenius Kabi sells Otulfi, Accord sells Imuldosa and Hikma sells Starjemza. Only Amgen, Celltrion and Biocon commercialize their own products in the US.

The Business Development Read

• The developer-plus-partner model works. Asian and European developers that own the molecule and the manufacturing, paired with Western companies that own payer and distribution relationships, produced most of the class.
• Chinese developers are now in the US market. Bio-Thera’s Starjemza is an interchangeable US biosimilar developed in China and licensed to Hikma, a template for future cross-border biosimilar deals.
• Margins compress quickly. With eight competitors and 80% to 90% list-price discounts at launch, returns depend on manufacturing cost and on winning private-label and formulary contracts.
• The next classes are larger and harder. Developers are moving to molecules such as pembrolizumab, aflibercept and denosumab, covered in our biosimilar market analysis.

For a developer deciding whether to enter a class, Stelara offers a clear lesson. Being first earned Amgen a period of exclusive interchangeability and a private-label launch partner, but within a year seven competitors were on the market, most of them interchangeable. Sustainable returns now come from low-cost manufacturing at scale, from supply agreements with pharmacy benefit managers, and from building portfolios across several molecules, which is why many of the companies above are working on the next immunology and oncology classes at the same time. Our CDMO market analysis covers the manufacturing side of that equation, and our licensing guide explains the developer-and-partner structures used across the class.

The Bottom Line

Eight biosimilars to Stelara are FDA-approved and on the US market, most of them interchangeable, and together they took 42% of the market within about a year of launch. Deep list-price discounts, private labels and fast formulary changes made Stelara the fastest-moving immunology biosimilar class so far, and its developer map, from Korea to China, shows where the next wave of biosimilar licensing deals will come from.

If you are developing or licensing a biosimilar and want a Western or Asian commercial partner, talk to our team.