Last updated: September 8, 2026
Guselkumab, marketed by Johnson & Johnson as Tremfya, is a commercially established interleukin-23 p19 inhibitor with expanding exposure across psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn's disease. U.S. sales increased from approximately $2.1 billion in 2022 to $2.8 billion in 2023 and about $3.6 billion in 2024, driven by dermatology growth and new gastroenterology indications.[1] The principal commercial risks are competition from risankizumab, biologic price pressure, biosimilar development after 2029, and the eventual erosion of the psoriasis market.
How large is the guselkumab market?
Guselkumab competes in several high-value immune-mediated disease markets:
| Market |
Primary competitors |
Guselkumab position |
| Plaque psoriasis |
Risankizumab, secukinumab, ixekizumab, bimekizumab, deucravacitinib |
Established IL-23 option with strong efficacy and dosing convenience |
| Psoriatic arthritis |
Risankizumab, secukinumab, ixekizumab, TNF inhibitors, JAK inhibitors |
Broad positioning across skin and joint disease |
| Ulcerative colitis |
Ustekinumab, risankizumab, vedolizumab, infliximab, upadacitinib |
Newly expanded entrant with subcutaneous maintenance dosing |
| Crohn's disease |
Risankizumab, ustekinumab, vedolizumab, infliximab, upadacitinib |
Important growth market following 2024 approval |
The commercial opportunity has shifted from a dermatology-led product to a multi-indication immunology franchise. Crohn's disease and ulcerative colitis increase the addressable population and create prescribing opportunities with gastroenterologists, while psoriasis and psoriatic arthritis provide the established revenue base.
The key strategic advantage is class validation. IL-23 inhibitors have gained share from tumor necrosis factor inhibitors and older biologics because of efficacy, tolerability, and less frequent maintenance dosing. The principal competitive threat is AbbVie's Skyrizi, which has a similar mechanism and is approved across psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
What are Tremfya sales and the financial trajectory?
Johnson & Johnson reported the following worldwide Tremfya sales:
| Fiscal year |
Tremfya sales |
Year-over-year change |
| 2022 |
Approximately $2.1 billion |
Approximately 31% |
| 2023 |
Approximately $2.8 billion |
Approximately 32% |
| 2024 |
Approximately $3.6 billion |
Approximately 27% |
Source: Johnson & Johnson annual reports.[1-3]
The sales trajectory reflects three phases:
- 2017-2020: psoriasis launch and early adoption. Tremfya entered the market as a selective IL-23 inhibitor with dosing every eight weeks after loading.
- 2020-2023: psoriatic arthritis expansion. The additional indication widened physician adoption and increased use in patients with both skin and joint disease.
- 2024 onward: gastroenterology expansion. U.S. approvals for ulcerative colitis and Crohn's disease increased the revenue ceiling and diversified sales beyond dermatology.
Tremfya is now one of Johnson & Johnson's largest growth products. The brand helps offset the long-term erosion risk affecting Stelara, another J&J immunology product whose U.S. exclusivity position is being challenged by biosimilars.
What is the likely peak-sales profile?
The product's peak-sales potential depends on uptake in inflammatory bowel disease, the durability of its competitive position against Skyrizi, and the timing of biosimilar entry. The most important variables are:
- Conversion of existing Stelara and anti-TNF patients.
- Gastroenterology adoption after the 2024 approvals.
- Relative efficacy in Crohn's disease and ulcerative colitis.
- Payer formulary placement.
- The ability to maintain premium pricing against Skyrizi and other IL-23 therapies.
- The timing of U.S. biosimilar entry after the 12-year reference-product exclusivity period.
A reasonable commercial interpretation is that Tremfya remains in its expansion phase rather than its mature-product phase. Revenue growth should decelerate as the base increases, but new IBD indications could extend the product's growth cycle through the second half of the decade.
When did the FDA approve guselkumab?
The FDA approved Tremfya for the following indications:
| Date |
Indication |
Regulatory event |
| July 2017 |
Moderate-to-severe plaque psoriasis in adults eligible for systemic therapy or phototherapy |
Initial U.S. approval |
| July 2020 |
Active psoriatic arthritis in adults |
Label expansion |
| September 2024 |
Moderately to severely active Crohn's disease in adults |
Label expansion |
| September 2024 |
Moderately to severely active ulcerative colitis in adults |
Label expansion |
The Crohn's disease and ulcerative colitis approvals were based on clinical programs showing efficacy in induction and maintenance treatment. Tremfya uses intravenous induction in the IBD setting followed by subcutaneous maintenance, while psoriasis and psoriatic arthritis use subcutaneous dosing regimens.[4-7]
No biosimilar to guselkumab had received FDA approval as of the end of 2024. The product is a biologic reference product, so future competitors will follow the Biologics Price Competition and Innovation Act pathway rather than the conventional abbreviated new drug application pathway.
What patents protect guselkumab?
Guselkumab is protected by a layered biologic patent estate rather than a single small-molecule composition patent. The relevant categories include:
- Antibodies that bind the p19 subunit of interleukin-23.
- Specific antibody sequences and related variants.
- Antibody production and cell-line methods.
- Pharmaceutical compositions.
- Dosing regimens for psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
- Use patents covering treatment of inflammatory diseases.
Public patent records indicate that the U.S. estate extends beyond the initial 2017 launch period through a combination of core antibody patents, continuation applications, formulation claims, and method-of-treatment patents. The commercially relevant patent protection is generally expected to extend into the early-to-mid 2030s, depending on the patent family, terminal disclaimers, patent-term adjustment, patent-term extension, and the validity of individual claims.
Because Tremfya is a biologic, its patent status must be analyzed through the FDA Purple Book, USPTO records, and litigation filings. It does not use the conventional Orange Book listing structure applicable to most small-molecule drugs.
What is the Orange Book status of Tremfya?
Tremfya is not an Orange Book-listed small-molecule reference drug. The applicable regulatory framework is the Purple Book, which identifies licensed biological products and reference products for biosimilar and interchangeable-product analysis.[8]
This distinction has practical consequences:
- A generic company cannot file a standard ANDA for guselkumab.
- A future competitor must generally file a 351(k) biosimilar application.
- Patent disputes may proceed under the BPCIA patent-exchange process and related federal litigation.
- Patent information can be distributed across multiple families rather than presented in the familiar Orange Book format.
When does guselkumab lose exclusivity?
Guselkumab received its first U.S. biologic license in 2017. The BPCIA provides 12 years of reference-product exclusivity before FDA approval of a biosimilar may become effective, subject to statutory requirements and litigation outcomes. The practical U.S. biosimilar approval barrier therefore reaches approximately 2029.[9]
That date does not necessarily mean immediate market entry. Actual launch timing will depend on:
- Patent validity and infringement disputes.
- Any settlement between J&J and a biosimilar applicant.
- Patent-term adjustment or extension.
- The scope of formulation, dosing, and manufacturing patents.
- The commercial readiness of a biosimilar manufacturer.
- FDA review timing.
The economically important patent window may extend beyond 2029 even if the statutory exclusivity period ends then. A biosimilar could face claims directed to manufacturing, dosing, or specific clinical uses after the primary reference-product exclusivity period.
What biosimilar and generic entry risks exist?
Biosimilar risk
The near-term biosimilar risk is low compared with Stelara because no approved guselkumab biosimilar was publicly identified by the end of 2024. The longer-term risk is material because guselkumab is a large revenue product with a validated mechanism and a broad patient population.
Likely biosimilar developers include companies with established immunology portfolios and complex-biologic manufacturing capabilities. Potential participants could include Samsung Bioepis, Celltrion, Sandoz, Fresenius Kabi, Biocon Biologics, Amgen, and large Chinese biologics manufacturers, although a company's participation would require a specific filing or public development disclosure.
Generic risk
Conventional generic entry is not relevant. The principal substitution risk comes from:
- Biosimilars to guselkumab.
- Biosimilars to competing biologics.
- Lower-cost IL-23 or IL-12/23 products.
- Oral immunomodulators such as JAK and TYK2 inhibitors.
- Payer-mandated switching within therapeutic classes.
Biosimilar substitution for monoclonal antibodies is more complex than small-molecule substitution. Switching policy, formulary controls, physician preference, and interchangeability determinations will influence market penetration.
Which companies are challenging guselkumab commercially?
The most important commercial challenger is AbbVie with Skyrizi, or risankizumab-rzaa. Both products target IL-23 biology and compete across psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
| Product |
Company |
Mechanism |
Key commercial strength |
| Tremfya |
Johnson & Johnson |
IL-23 p19 inhibitor |
Broad label, established dermatology franchise, IBD expansion |
| Skyrizi |
AbbVie |
IL-23 p19 inhibitor |
Strong IBD growth, major immunology sales platform |
| Stelara |
Johnson & Johnson |
IL-12/23 p40 inhibitor |
Large installed base but biosimilar erosion risk |
| Bimzelx |
UCB |
IL-17A/F inhibitor |
High psoriasis efficacy and expanding indications |
| Cosentyx |
Novartis |
IL-17A inhibitor |
Broad immunology presence |
| Taltz |
Eli Lilly |
IL-17A inhibitor |
Established psoriasis and psoriatic arthritis position |
| Rinvoq |
AbbVie |
JAK inhibitor |
Oral administration and strong IBD efficacy, balanced against safety restrictions |
Skyrizi is the closest direct comparator. The two products have similar mechanisms and overlapping indications, which raises the importance of head-to-head efficacy, dosing, patient persistence, payer access, and physician familiarity.
How strong is the guselkumab patent estate?
The estate is commercially strong but not indefinite.
Strengths
- Biologic exclusivity protects the product against approval of a biosimilar until approximately 2029.
- Multiple patent families can create overlapping barriers.
- The product has several indications, which increases the value of method-of-use claims.
- Manufacturing and analytical complexity raises development costs for biosimilar competitors.
- IBD approvals add later-issued clinical and dosing claims to the product's protection profile.
Vulnerabilities
- Antibody patents can face validity challenges involving written description, enablement, obviousness, and claim scope.
- Broad genus claims may be narrowed during litigation.
- Biosimilar developers can launch after resolving selected patent disputes rather than all potential claims.
- Older psoriasis claims may expire before newer IBD-related claims.
- A biosimilar may initially compete in non-patent-blocked indications while excluding protected uses from its label.
The estate should therefore be assessed by patent family and indication, not through a single expiration date.
What patent litigation affects guselkumab?
As of the end of 2024, no major public U.S. biosimilar litigation campaign had materially disrupted Tremfya commercialization. This differs from Stelara, where J&J faced active challenges and negotiated settlements involving biosimilar applicants.
The absence of a major disclosed dispute does not eliminate future risk. A biosimilar applicant could trigger BPCIA litigation after filing, and disputes could focus on:
- Antibody sequence claims.
- Formulation claims.
- Manufacturing processes.
- Dosing schedules.
- Crohn's disease and ulcerative colitis treatment methods.
- Patent-term calculations.
Has Johnson & Johnson licensed guselkumab?
Janssen Biotech, a Johnson & Johnson company, commercializes Tremfya. No major standalone third-party licensing transaction has been publicly associated with the current commercial rights to guselkumab. The product is principally managed within the Johnson & Johnson pharmaceutical portfolio.
The commercial model differs from products obtained through large external licensing deals. J&J retains control over global development, regulatory strategy, manufacturing, and commercialization, which supports margin capture but leaves the company responsible for the full cost of lifecycle management.
What manufacturing and intellectual-property barriers protect guselkumab?
Guselkumab manufacturing requires mammalian-cell expression, purification, viral clearance, analytical characterization, formulation, sterile fill-finish, and cold-chain distribution. These requirements create operational barriers beyond the patent estate.
The principal manufacturing risks for a biosimilar developer include:
- Matching higher-order structure and glycosylation.
- Demonstrating comparable potency and binding.
- Establishing a reliable commercial cell line.
- Scaling production without changing critical quality attributes.
- Meeting global comparability requirements.
- Supporting multiple delivery devices and presentations.
For J&J, manufacturing scale and supply reliability support continued market access. For competitors, these requirements increase development costs and lengthen the path from patent challenge to commercial launch.
What revenue exposure does J&J face?
Tremfya's approximate $3.6 billion in 2024 sales represents significant growth-product exposure for Johnson & Johnson. The risk is not concentrated in a single indication because revenue is spread across dermatology, rheumatology, and gastroenterology.
The main revenue scenarios are:
| Scenario |
Commercial effect |
| Strong IBD uptake and stable payer access |
Sustained double-digit growth followed by a high revenue plateau |
| Skyrizi gains share in IBD |
Lower peak sales and faster growth deceleration |
| Biosimilar entry near 2029-2031 |
Rapid price compression and volume migration |
| Delayed biosimilar launch |
Longer period of premium pricing |
| Strong Stelara-to-Tremfya conversion |
Internal portfolio defense against Stelara erosion |
| Increased oral therapy use |
Pressure on biologic initiation and persistence |
Tremfya is also strategically important because it can replace some revenue lost from Stelara as Stelara biosimilars enter the U.S. market. That substitution may reduce the net impact of J&J's immunology patent cliff.
How does guselkumab compare with Skyrizi?
| Attribute |
Tremfya |
Skyrizi |
| Company |
Johnson & Johnson |
AbbVie |
| Target |
IL-23 p19 |
IL-23 p19 |
| Initial U.S. psoriasis approval |
2017 |
2019 |
| Psoriatic arthritis |
Approved |
Approved |
| Crohn's disease |
Approved in 2024 |
Approved |
| Ulcerative colitis |
Approved in 2024 |
Approved |
| Maintenance positioning |
Infrequent subcutaneous dosing |
Infrequent subcutaneous dosing |
| Main strategic advantage |
Earlier market entry and broad J&J immunology infrastructure |
Strong AbbVie immunology execution and major IBD momentum |
| Main risk |
Direct class competition and future biosimilar erosion |
Same-class competition and eventual patent exposure |
The competition is likely to be determined less by mechanism and more by comparative outcomes, formulary access, patient persistence, induction convenience, and physician experience.
Key Takeaways
- Tremfya sales rose from about $2.1 billion in 2022 to approximately $3.6 billion in 2024.
- The 2024 Crohn's disease and ulcerative colitis approvals materially expanded the commercial opportunity.
- Skyrizi is the closest competitor and the principal threat to future market share.
- Guselkumab is protected by biologic exclusivity until approximately 2029, with additional patent protection expected to extend into the early-to-mid 2030s for parts of the estate.
- Tremfya is not an Orange Book-listed small molecule; the Purple Book and USPTO records are the relevant sources for biologic and patent analysis.
- No major public guselkumab biosimilar litigation campaign had disrupted U.S. commercialization by the end of 2024.
- The key financial question is whether IBD growth can offset future pressure from IL-23 competition and biosimilar entry.
FAQs
Is guselkumab a high-revenue biologic?
Yes. Tremfya generated approximately $3.6 billion in worldwide sales in 2024 and is one of Johnson & Johnson's major growth immunology products.
Is Tremfya the same type of drug as Skyrizi?
Yes. Both are selective interleukin-23 p19 inhibitors, but they are separate antibody products developed and commercialized by different companies.
Can a generic company make guselkumab?
No conventional generic can be approved for guselkumab. A competitor must generally pursue the FDA's 351(k) biosimilar pathway.
Does Tremfya have an interchangeable biosimilar?
No FDA-approved interchangeable guselkumab biosimilar had been identified by the end of 2024.
What is the biggest long-term risk to Tremfya revenue?
The largest long-term risk is combined competition from Skyrizi and other advanced immunology products, followed by biosimilar entry after the U.S. biologic exclusivity period.
References
- Johnson & Johnson. (2025). 2024 annual report. https://www.jnj.com
- Johnson & Johnson. (2024). 2023 annual report. https://www.jnj.com
- Johnson & Johnson. (2023). 2022 annual report. https://www.jnj.com
- U.S. Food and Drug Administration. (2017). FDA approves new treatment for moderate-to-severe plaque psoriasis. https://www.fda.gov
- U.S. Food and Drug Administration. (2020). FDA approves guselkumab for active psoriatic arthritis. https://www.fda.gov
- U.S. Food and Drug Administration. (2024). FDA approves guselkumab for adults with moderately to severely active Crohn's disease. https://www.fda.gov
- U.S. Food and Drug Administration. (2024). FDA approves guselkumab for adults with moderately to severely active ulcerative colitis. https://www.fda.gov
- U.S. Food and Drug Administration. (2024). Purple Book: Database of licensed biological products. https://purplebooksearch.fda.gov
- U.S. Congress. (2010). Biologics Price Competition and Innovation Act of 2009, Pub. L. No. 111-148, ยงยง7001-7002. https://www.congress.gov
