Guselkumab - Biologic Drug Details

Summary for guselkumab

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for guselkumab

Recent Clinical Trials for guselkumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Xian-Janssen Pharmaceutical Ltd.	PHASE4
University of California, San Francisco	PHASE4
Universitaire Ziekenhuizen KU Leuven	PHASE4

See all guselkumab clinical trials

Pharmacology for guselkumab

Mechanism of Action	Interleukin-23 Antagonists
Established Pharmacologic Class	Interleukin-23 Antagonist

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for guselkumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for guselkumab Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Janssen Biotech, Inc.	TREMFYA	guselkumab	Injection	761061	10,065,995	2032-03-26	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	TREMFYA	guselkumab	Injection	761061	10,155,823	2035-08-21	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	TREMFYA	guselkumab	Injection	761061	10,233,256	2035-11-25	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	TREMFYA	guselkumab	Injection	761061	10,233,257	2037-09-01	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	TREMFYA	guselkumab	Injection	761061	10,301,389	2033-06-13	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for guselkumab Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Janssen Biotech, Inc.	TREMFYA	guselkumab	Injection	761061	10,273,252	2036-06-14	Patent claims search
Janssen Biotech, Inc.	TREMFYA	guselkumab	Injection	761061	10,590,182	2036-02-23	Patent claims search
Janssen Biotech, Inc.	TREMFYA	guselkumab	Injection	761061	11,016,099	2036-09-16	Patent claims search
Janssen Biotech, Inc.	TREMFYA	guselkumab	Injection	761061	11,168,134	2039-09-18	Patent claims search
Janssen Biotech, Inc.	TREMFYA	guselkumab	Injection	761061	11,220,541	2036-12-16	Patent claims search

International Patents for guselkumab

Country	Patent Number	Estimated Expiration
Costa Rica	20180420
Portugal	3615146
Brazil	112012012514
Turkey	201907573
Singapore	11201701135W

Supplementary Protection Certificates for guselkumab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
PA2018010,C1971366	Lithuania		PRODUCT NAME: GUSELKUMABAS; REGISTRATION NO/DATE: EU/1/17/1234 20171110
LUC00263	Luxembourg		PRODUCT NAME: ANIFROLUMAB; AUTHORISATION NUMBER AND DATE: EU/1/21/1623 20220215
C 2018 017	Romania		PRODUCT NAME: GUSELKUMAB; NATIONAL AUTHORISATION NUMBER: EU/1/17/1234; DATE OF NATIONAL AUTHORISATION: 20171110; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1234; DATE OF FIRST AUTHORISATION IN EEA: 20171110
301334	Netherlands		PRODUCT NAME: VILOBELIMAB; REGISTRATION NO/DATE: EU/1/24/1884 20250114
22C1019	France		PRODUCT NAME: ANIFROLUMAB; REGISTRATION NO/DATE: EU/1/21/1623 20220215

Market Dynamics and Financial Trajectory for Guselkumab

Last updated: February 20, 2026

What is guselkumab and how does it stand in the biologic landscape?

Guselkumab (brand name Tremfya) is a monoclonal antibody that targets interleukin-23 (IL-23), approved for plaque psoriasis and psoriatic arthritis. It was developed by Janssen Pharmaceuticals, a Johnson & Johnson subsidiary. Since its FDA approval in July 2017, guselkumab has gained market share in the biologic segment focused on moderate-to-severe psoriasis.

How does guselkumab's market size compare to other IL-23 inhibitors?

Product	Indications	Launch Year	2022 Global Sales (USD)	Market Share (Psoriasis)	Key Competitors
Guselkumab (Tremfya)	Psoriasis, psoriatic arthritis	2017	1.2 billion	35%	Risankizumab, tildrakizumab
Risankizumab (Skyrizi)	Psoriasis, Crohn’s disease	2019	2.4 billion	46%	Guselkumab
Tildrakizumab (Ilumya)	Psoriasis	2018	Data not published	5-8%	Guselkumab

Guselkumab trails risankizumab in sales but maintains a significant share in the IL-23 class.

What are the key factors influencing guselkumab’s market growth?

1. Expanding Indications

Guselkumab received approval for psoriatic arthritis in 2020, broadening its revenue base, which historically centered on psoriasis. Regulatory submissions for Crohn's disease and hidradenitis suppurativa are ongoing, which could further expand prescriptions.

2. Competitive Landscape

Risankizumab (AbbVie) holds the market lead with higher sales, benefiting from early market entry and broader indication approvals. Tildrakizumab has a smaller share but gains from lower cost and niche positioning. Biosimilars are unlikely in the near term due to patent protections extending into the late 2020s.

3. Pricing and Reimbursement Dynamics

Guselkumab’s average wholesale price (AWP) in the US is approximately $5,200 per year per patient. Payer negotiations, especially in Europe and emerging markets, influence net pricing, affecting revenue growth.

4. Patients’ Preference and Adherence

Dosing schedule (every 8 weeks after initial doses) promotes adherence compared to competing options. Safety profile remains stable, with low immunogenicity and infection risk.

5. Market Penetration Strategies

Johnson & Johnson’s direct sales force focuses on rheumatology and dermatology clinics. Educational initiatives and patient assistance programs support uptake.

What are the projected financial trends for guselkumab?

1. Revenue Forecast

Year	Estimated Global Sales (USD)	Compound Annual Growth Rate (CAGR) (2023-2027)	Assumptions
2023	1.4 billion	8%	Expanded indication approvals
2024	1.52 billion		Increased market penetration
2025	1.65 billion		Entry into new markets
2026	1.78 billion		Price adjustments, competition
2027	1.92 billion		Biosimilar pressure pending

2. Margin Analysis

Gross margins in biologics are typically above 75%. R&D expenses for guselkumab are estimated at 10-12% of sales, moderate compared to the industry standard, driven by ongoing clinical trials and post-market surveillance.

3. Impact of Biosimilars

Biosimilar entry in the late 2020s could reduce prices by 20-30%, pressuring revenue and margins. However, high switching costs and patent protections mitigate immediate impact.

How are regulatory and policy changes affecting guselkumab’s market?

Recent FDA and EMA approvals for additional indications improve growth prospects. Price regulation policies in Europe may limit upside, but US formulary access remains favorable due to clinical differentiation.

Key Challenges and Risks

• Competition from newer IL-23 inhibitors with differentiated profiles.
• Delays or setbacks in registration trials for expanded indications.
• Pricing pressures and reimbursement restrictions.
• Patent litigation and biosimilar entry risks.

Key Opportunities

• Expanding into additional autoimmune conditions.
• Geographic expansion, especially in emerging markets.
• Combination therapy with other biologics or small molecules.

---

Key Takeaways

• Guselkumab holds a solid position in the IL-23 inhibitor market, with estimated 2022 sales of USD 1.2 billion.
• Risankizumab leads in sales, though guselkumab benefits from indication expansions and strategic positioning.
• Revenue is projected to grow at approximately 8% annually through 2027, reaching USD 1.92 billion.
• Biosimilar competition and price regulation pose risks, but patent protections provide near-term revenue stability.
• Ongoing clinical trials and market expansion efforts are central to growth.

---

FAQs

1. What are the primary competitors to guselkumab?
Risankizumab and tildrakizumab are main competitors, with risankizumab leading in sales.

2. How significant is the biosimilar threat for guselkumab?
Bio-similar versions are unlikely before late 2020s due to patent rights; their introduction could reduce prices by 20-30%.

3. Which regions offer the highest growth potential for guselkumab?
Emerging markets in Asia, Latin America, and Eastern Europe present significant growth opportunities.

4. What is the typical pricing strategy for guselkumab?
Pricing is aligned with peer biologics, around USD 5,200 annually in the US, with negotiations influencing net prices.

5. How does guselkumab compare in safety and efficacy?
It exhibits a favorable safety profile with low immunogenicity and is effective in reducing psoriasis severity with dosing every 8 weeks after initial doses.

---

References

[1] Johnson & Johnson. (2022). Tremfya (guselkumab) prescribing information.
[2] IQVIA. (2022). Biologic market overview.
[3] U.S. Food and Drug Administration. (2017). FDA approves Tremfya for plaque psoriasis.
[4] Bloomberg Industry Analysis. (2023). IL-23 inhibitor market report.