Last updated: September 5, 2026
Dapzura RT is Celltrion’s ustekinumab biosimilar, identified by the nonproprietary name ustekinumab-stba. It competes with Johnson & Johnson’s Stelara in plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. The commercial opportunity is substantial because Stelara generated approximately $10.4 billion in global sales in 2023, but Dapzura RT enters a crowded U.S. biosimilar market with several approved ustekinumab products and negotiated entry dates.[1][2]
Dapzura RT’s financial trajectory will depend on launch timing, payer formulary access, net pricing, interchangeability strategy, and Celltrion’s ability to convert Stelara volume in inflammatory bowel disease and dermatology. Public filings do not yet disclose standalone Dapzura RT revenue, gross margin, or market share.
What is Dapzura RT and which drug does it compete with?
Dapzura RT is a biosimilar to Stelara, whose active ingredient is ustekinumab. Ustekinumab is a monoclonal antibody that binds the p40 subunit shared by interleukin-12 and interleukin-23.
| Product |
Active ingredient |
Sponsor |
Reference product |
Main U.S. indications |
| Dapzura RT |
Ustekinumab-stba |
Celltrion |
Stelara |
Plaque psoriasis, psoriatic arthritis, Crohn’s disease, ulcerative colitis |
| Stelara |
Ustekinumab |
Janssen Biotech, Johnson & Johnson |
Reference biologic |
Same disease areas |
| Selarsdi |
Ustekinumab-aekn |
Teva and Alvotech |
Stelara |
Stelara-aligned indications |
| Wezlana |
Ustekinumab-auub |
Amgen |
Stelara |
Stelara-aligned indications |
| Pyzchiva |
Ustekinumab-ttwe |
Samsung Bioepis and Sandoz |
Stelara |
Stelara-aligned indications |
| Otulfi |
Ustekinumab-aauz |
Fresenius Kabi |
Stelara |
Stelara-aligned indications |
| Yesintek |
Ustekinumab-kfce |
Biocon Biologics |
Stelara |
Stelara-aligned indications |
Dapzura RT is administered by subcutaneous injection for most maintenance regimens. Stelara also has an intravenous induction regimen for Crohn’s disease and ulcerative colitis. The availability of an intravenous presentation and the exact approved presentations affect hospital, specialty-pharmacy, and gastroenterology uptake.
What is the FDA status of Dapzura RT?
Dapzura RT received FDA approval through the 351(k) biosimilar pathway. Its reference product is Stelara, and the approval covers the major immunology indications for which Stelara was approved.
The FDA biosimilar pathway requires analytical, pharmacokinetic, pharmacodynamic, immunogenicity, and clinical evidence sufficient to establish biosimilarity. The pathway does not require a separate, full clinical trial program for every approved indication.
Dapzura RT should not be confused with an interchangeable biosimilar unless the FDA specifically grants that designation. Interchangeability can improve substitution potential at the pharmacy level, subject to state law and payer policy. Biosimilarity alone does not create automatic pharmacy substitution.
Is Dapzura RT interchangeable with Stelara?
The answer depends on the FDA approval designation for the specific product and presentation. A biosimilar may be approved without interchangeability. An interchangeable designation requires additional statutory evidence and can affect pharmacy substitution rules.
For commercial forecasting, interchangeability is less important in physician-administered gastroenterology settings than in retail and specialty-pharmacy channels. Payer-mandated switching can still drive utilization even where automatic pharmacy substitution is unavailable.
What patents protect Stelara and Dapzura RT?
Dapzura RT is protected primarily by biologic regulatory exclusivity, Celltrion’s patent position, manufacturing know-how, and commercial contracts. Stelara’s original composition patent has expired, but secondary patents covering formulations, dosing, methods of treatment, and manufacturing extended the reference product’s market protection.
The Orange Book does not list biologic patents in the same way it lists patents for small-molecule drugs. Stelara-related biologic patent information is generally evaluated through FDA Purple Book records, patent litigation, inter partes review proceedings, and public settlement disclosures.
When did Stelara lose exclusivity?
Stelara’s 12-year U.S. reference-product exclusivity expired in 2023. Patent settlements with biosimilar developers, rather than the regulatory exclusivity date alone, determined actual launch timing.
Johnson & Johnson negotiated settlements with multiple biosimilar companies. The settlements established licensed launch dates that generally preceded the complete expiration of all asserted secondary patent claims. These agreements reduced immediate litigation uncertainty while preserving a period of commercial protection for Stelara.
What patent barriers affect Dapzura RT?
The key barriers are:
- Stelara formulation patents covering high-concentration or low-volume presentations.
- Dosing and administration patents covering treatment schedules.
- Manufacturing and cell-culture patents.
- Device and delivery-system patents.
- Patent settlements that limit the earliest commercial launch date.
Celltrion’s ability to sell Dapzura RT depends on its license rights under the settlement structure and on whether remaining patents are valid, enforceable, and infringed. The commercial significance of a patent is therefore tied to the negotiated launch license, not only to the stated expiration date.
When did Dapzura RT enter the U.S. market?
Dapzura RT was approved in 2025. Its U.S. commercial launch is governed by Celltrion’s patent settlement with Janssen and by the commercial launch strategy selected for the product.
The U.S. market began receiving Stelara biosimilar competition in 2025. The staggered entry of multiple products reduces the likelihood that any single biosimilar will capture the full displaced Stelara volume.
| Event |
Commercial significance |
| Stelara FDA approval |
Established the reference biologic |
| 2023 |
Expiration of U.S. biologic exclusivity |
| 2023-2024 |
FDA approval of multiple ustekinumab biosimilars |
| 2024-2025 |
Patent settlements and licensed launch windows |
| 2025 |
Initial U.S. Stelara biosimilar launches |
| 2025 onward |
Payer contracting, formulary competition, and price erosion |
How large is the market opportunity for Dapzura RT?
The addressable market is one of the largest among immunology biosimilars. Stelara sales reached about $10.4 billion globally in 2023, with the United States representing the largest market.[1]
The opportunity is divided across four segments:
- Gastroenterology, including Crohn’s disease and ulcerative colitis.
- Dermatology, including moderate-to-severe plaque psoriasis.
- Rheumatology, including active psoriatic arthritis.
- Hospital and specialty-pharmacy channels.
Gastroenterology is likely to be the most commercially valuable segment because Stelara has high annual treatment cost, intravenous induction, and long-term maintenance use. Dermatology has a larger number of treated patients but is highly sensitive to formulary controls and competitive rebate structures.
What is the estimated revenue potential?
No public filing reports Dapzura RT revenue separately. A scenario framework is more reliable than a point estimate.
| Scenario |
Assumed share of displaced Stelara U.S. volume |
Indicative commercial outcome |
| Low case |
2%-5% |
Limited uptake because of crowded competition and weak formulary position |
| Base case |
5%-10% |
Meaningful biosimilar revenue with selective payer and specialty-pharmacy access |
| High case |
10%-15% |
Strong Celltrion contracting, favorable launch timing, and broad gastroenterology adoption |
If the U.S. Stelara market represents several billion dollars annually, a 5% share could produce several hundred million dollars in gross sales before rebates and channel deductions. Net revenue could be materially lower because biosimilar competition is likely to produce aggressive discounts.
These scenarios are market-sizing ranges, not reported company guidance. Celltrion’s consolidated financial statements are the appropriate source for realized revenue once the product is separately reported or included in a material immunology segment.
How will Dapzura RT pricing affect its financial trajectory?
Dapzura RT will compete on net price rather than list price alone. The principal commercial levers are:
- Wholesale acquisition cost.
- Rebates to commercial insurers.
- Medicaid and government-program discounts.
- Specialty-pharmacy fees.
- Distributor margins.
- Patient-support and copay programs.
- Contracting with integrated delivery networks.
A crowded biosimilar market normally creates a split strategy. One product may seek a high-discount position to secure formulary preference, while another maintains a smaller discount to protect net price and physician confidence.
Celltrion has experience commercializing biosimilars in the United States and Europe. That experience supports manufacturing scale and contracting capability, but the number of competing ustekinumab biosimilars makes rapid price expansion unlikely.
Which companies are challenging Stelara?
The primary competitors include Amgen, Samsung Bioepis, Sandoz, Fresenius Kabi, Biocon Biologics, Teva, and Celltrion.
How does Dapzura RT compare with competing Stelara biosimilars?
| Factor |
Dapzura RT |
Competing products |
| Sponsor |
Celltrion |
Large pharmaceutical and biosimilar manufacturers |
| Reference product |
Stelara |
Stelara |
| Disease coverage |
Broad Stelara-aligned indications |
Generally broad, subject to label details |
| Competitive advantage |
Celltrion manufacturing scale and biosimilar experience |
Earlier launch, payer relationships, interchangeability, or price |
| Main weakness |
Crowded entry and limited first-mover advantage |
Same market-access and price pressures |
| Key commercial variable |
Formulary placement and net discount |
Contracting and switching programs |
The most important differentiator may be payer access rather than clinical positioning. Because all products rely on biosimilarity, physicians and payers are likely to evaluate net cost, supply reliability, patient-support infrastructure, and substitution rules.
What generic or biosimilar entry risks exist for Dapzura RT?
Traditional generic entry risk does not apply because Dapzura RT is a biologic. Its principal risk is competing biosimilar entry.
The main risks are:
- Multiple approved products competing for the same Stelara volume.
- Price erosion from payer tenders and rebate competition.
- Delayed switching in patients who are clinically stable.
- Physician preference for maintaining the reference product.
- Limited interchangeability or state-level substitution restrictions.
- Manufacturing interruptions involving complex biologic production.
- Greater competition in gastroenterology, where treatment continuity is commercially important.
- Newer mechanisms, including IL-23 inhibitors, taking share from the entire ustekinumab class.
The last risk is strategic rather than patent-based. Drugs such as guselkumab, risankizumab, mirikizumab, and other IL-23-directed products may reduce the long-term growth of the ustekinumab market, especially in inflammatory bowel disease and psoriasis.
What is the licensing and settlement landscape?
Celltrion’s U.S. launch depends on patent settlement and license arrangements with Janssen. Biosimilar settlements typically provide the developer with a specified launch date in exchange for resolution or limitation of patent litigation.
These agreements can include:
- A licensed commercial entry date.
- Geographic restrictions.
- Covenants not to sue.
- Waivers or releases for specified patents.
- Manufacturing or supply provisions.
- Confidential economic terms.
The existence of a settlement reduces litigation risk but does not eliminate commercial risk. A launch license can still result in weak economics if several competitors enter at nearly the same time.
What litigation affects Dapzura RT?
The relevant litigation is primarily patent litigation concerning Stelara and other ustekinumab biosimilars. The disputes concern infringement and validity of secondary patents, including formulation and dosing claims.
The principal legal questions are:
- Whether Celltrion’s product infringes asserted patents.
- Whether the patents are valid and enforceable.
- Whether a settlement permits launch before patent expiration.
- Whether manufacturing activities create separate infringement exposure.
- Whether the FDA-approved label creates method-of-use risk.
Because Dapzura RT is a biosimilar, litigation risk is concentrated before and around launch. Once multiple products are commercial, the risk shifts toward price competition, supply performance, payer contracting, and market-share retention.
How strong is the Dapzura RT patent estate?
Dapzura RT’s direct patent estate is less important than the product’s regulatory and manufacturing barriers. A biosimilar sponsor typically relies on:
- Cell-line and cell-culture know-how.
- Purification and analytical methods.
- Formulation and stability data.
- Device configuration.
- Trade secrets.
- Regulatory exclusivity and launch-license rights.
The estate is commercially stronger if Celltrion has proprietary manufacturing claims, reliable supply capacity, and a favorable settlement. It is weaker if the product is one of many clinically substitutable biosimilars and lacks interchangeability or payer preference.
What is the expected financial trajectory for Dapzura RT?
Dapzura RT is likely to follow a front-loaded biosimilar launch curve:
- Initial launch period: low reported revenue while contracts are established and inventory moves through specialty channels.
- Expansion period: rapid volume growth if payers adopt preferred formulary positioning.
- Mature period: price erosion as competing ustekinumab biosimilars gain access.
- Stabilization period: revenue depends on manufacturing cost, share retention, and the size of the remaining Stelara market.
Celltrion’s upside is greatest if it secures early contracts with national insurers and gastroenterology networks. The downside case involves a fragmented market in which each biosimilar captures a small share and net prices decline faster than volume expands.
Key Takeaways
- Dapzura RT is Celltrion’s ustekinumab biosimilar to Stelara.
- Its target markets are psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
- Stelara generated approximately $10.4 billion in global sales in 2023.
- Dapzura RT entered a crowded U.S. biosimilar market in 2025.
- The Orange Book is not the principal patent resource for Stelara; Purple Book records, patent litigation, and settlement agreements are more relevant.
- No standalone Dapzura RT revenue has been publicly disclosed.
- The strongest commercial opportunity is in gastroenterology, where Stelara treatment costs and annual volume are high.
- The main risks are payer-driven price erosion, multiple biosimilar competitors, limited interchangeability, and migration to newer IL-23 therapies.
- Celltrion’s financial outcome will depend more on formulary access and net pricing than on FDA approval alone.
FAQs About Dapzura RT
Is Dapzura RT a generic version of Stelara?
No. Dapzura RT is a biologic biosimilar, not a traditional small-molecule generic. It is designed to be highly similar to Stelara without clinically meaningful differences in safety, purity, and potency.
Is Dapzura RT approved for ulcerative colitis?
Yes. Its Stelara-aligned approval includes ulcerative colitis, subject to the FDA-approved label and presentation-specific terms.
Does Dapzura RT have a different active ingredient from Stelara?
No. Both products use ustekinumab as the active biologic substance. Dapzura RT uses the biosimilar suffix ustekinumab-stba.
Will Dapzura RT reduce Stelara spending?
It is expected to create downward pricing pressure, but the savings will depend on payer contracting, rebate levels, switching rates, and the number of competing ustekinumab biosimilars.
Could Dapzura RT lose market share to newer IL-23 drugs?
Yes. Newer selective IL-23 therapies may compete with both Stelara and its biosimilars. This class-level substitution is a longer-term risk to Dapzura RT’s revenue trajectory.
References
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Johnson & Johnson. (2024). 2023 annual report. Johnson & Johnson.
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U.S. Food and Drug Administration. (2025). Purple Book: Database of licensed biological products. https://purplebooksearch.fda.gov/
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U.S. Food and Drug Administration. (2025). Dapzura RT prescribing information. U.S. Department of Health and Human Services.
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U.S. Food and Drug Administration. (2024). Biosimilar and interchangeable biosimilar products. https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars
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Celltrion Healthcare. (2025). Corporate and regulatory disclosures concerning ustekinumab biosimilar commercialization. Celltrion Healthcare.
