Certolizumab pegol - Biologic Drug Details

Summary for certolizumab pegol

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

Recent Clinical Trials for certolizumab pegol

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University of California, San Francisco	PHASE4
NYU Langone Health	PHASE2
South Valley University	NA

See all certolizumab pegol clinical trials

Pharmacology for certolizumab pegol

Mechanism of Action	Tumor Necrosis Factor Receptor Blocking Activity
Established Pharmacologic Class	Tumor Necrosis Factor Blocker

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 certolizumab pegol Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for certolizumab pegol 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
Ucb, Inc.	CIMZIA	certolizumab pegol	For Injection	125160		2021-06-06	DrugPatentWatch analysis and company disclosures
Ucb, Inc.	CIMZIA	certolizumab pegol	For Injection	125160		2021-09-10	DrugPatentWatch analysis and company disclosures
Ucb, Inc.	CIMZIA	certolizumab pegol	For Injection	125160		2028-06-18	DrugPatentWatch analysis and company disclosures
Ucb, Inc.	CIMZIA	certolizumab pegol	Injection	125160		2021-06-06	DrugPatentWatch analysis and company disclosures
Ucb, Inc.	CIMZIA	certolizumab pegol	Injection	125160		2021-09-10	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for certolizumab pegol 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
Ucb, Inc.	CIMZIA	certolizumab pegol	For Injection	125160		2036-12-20	Patent claims search
Ucb, Inc.	CIMZIA	certolizumab pegol	For Injection	125160		2037-03-16	Patent claims search
Ucb, Inc.	CIMZIA	certolizumab pegol	For Injection	125160		2034-02-13	Patent claims search
Ucb, Inc.	CIMZIA	certolizumab pegol	For Injection	125160		2033-11-05	Patent claims search
Ucb, Inc.	CIMZIA	certolizumab pegol	For Injection	125160		2036-08-10	Patent claims search

International Patents for certolizumab pegol

Country	Patent Number	Estimated Expiration
Cyprus	1121173
Portugal	2230308
Hungary	230553
Poland	218516
Russian Federation	2303604

Supplementary Protection Certificates for certolizumab pegol

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2019C/517	Belgium		PRODUCT NAME: CERTOLIZUMAB; AUTHORISATION NUMBER AND DATE: EU/1/09/544/001-002 20091006
LUC00109	Luxembourg		PRODUCT NAME: CIMZIA - CERTOLIZUMAB PEGOL; AUTHORISATION NUMBER AND DATE: EU/1/09/544/001; EU/1/09/544/002 20091006
C01287140/01	Switzerland		PRODUCT NAME: CERTOLIZUMAB PEGOL; REGISTRATION NO/DATE: SWISSMEDIC 57856 07.09.2007
CA 2010 00010	Denmark
122010000027	Germany		PRODUCT NAME: CIMZIA - CERTOLIZUMAB PEGOL IN ALLEN DEM GRUNDPATENT ZU GRUNDE LIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/09/544/001-002 20091001

Market Dynamics and Financial Trajectory for Certolizumab Pegol

Last updated: March 6, 2026

What Is Certolizumab Pegol?

Certolizumab pegol (Cimzia) is a biologic medication developed by UCB. It is a pegylated Fab fragment targeting tumor necrosis factor-alpha (TNF-α). Approved for multiple autoimmune conditions, including Crohn’s disease, rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis, it has established a notable presence since its 2009 U.S. approval.[1]

Market Size and Competitive Position

Global Market Valuation

The global biologic TNF inhibitors market was valued at approximately $31 billion in 2022. Certolizumab pegol accounted for roughly 4% within this segment, translating into an estimated market size of $1.2 billion.[2]

Key Competitors

Certolizumab pegol faces competition from:

• Adalimumab (Humira) – Dominates TNF class with $21 billion in sales in 2022.
• Infliximab (Remicade) – Annual sales at approximately $8 billion.
• Etanercept (Enbrel) – Generates around $6 billion annually.

Certolizumab pegol has a competitive advantage in specific indications like pregnancy-related Crohn’s disease due to the absence of antibody Fc regions, which limits placental transfer.[3]

Market Penetration and Adoption Trends

In autoimmune therapies, biosimilar entrants have eroded traditional biologic margins. Certolizumab pegol maintains a niche due to its unique pegylation and safety profile, but overall market share growth remains limited compared to adalimumab and infliximab.[4]

Revenue and Growth Patterns

Historical Sales Data

• 2015: ~$0.5 billion
• 2018: ~$0.9 billion
• 2022: ~$1.2 billion

The compound annual growth rate (CAGR) from 2015 through 2022 approximates 17%. Growth reflects increasing adoption in Crohn’s disease and increased use in newer indications.

Factors Influencing Financial Trajectory

• Indication expansion: Trials for ulcerative colitis, hidradenitis suppurativa, and other autoimmune diseases hold potential.
• Pricing strategies: UCB has maintained premium pricing with high reimbursement thresholds. The drug’s pricing ranged from $45,000 to $60,000 annually per patient in the U.S.[5]
• Patent exclusivity: Key patents expire in the mid-2020s, opening pathways for biosimilar entry. UCB invested in patent extensions through formulation tweaks and secondary patents until 2024.[6]

Impact of Biosimilars

Biosimilar entry predicted around 2024-2025 could reduce UCB’s pricing power. For crohn’s disease, biosimilars of infliximab and adalimumab already undercut prices by 20-40%, pressuring certolizumab’s revenues.

Regulatory and Market Access Landscape

• Regulatory approvals: EMA approved certolizumab pegol for Crohn’s disease, rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis.
• Market access barriers: Payers restrict use to patients who failed other TNFs, affecting volume growth.
• Pricing negotiations: UK’s NHS, in line with cost-effectiveness assessments, has negotiated discounts, affecting revenue potential.

Forward-Looking Financial Projections

Year	Estimated Revenue	Key Drivers
2023	~$1.3 billion	Market saturation, biosimilar threat
2024	~$1.2 billion	Biosimilar launch, patent expiry
2025	~$1 billion	Increased biosimilar competition
2026	<$900 million	Market share erosion

The revenue decline post-2024 anticipates biosimilar competition and reimbursement pressures. However, expansion into new indications could offset some losses.

Strategic Considerations

• Patent litigation: UCB actively defends patents to delay biosimilars.
• Orphan indication potential: Expanding label for rare conditions could sustain sales.
• Pricing innovation: Fixed-dose or combination therapies could boost margins despite biosimilar threats.

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Key Takeaways

• Certolizumab pegol’s revenue grew at a CAGR of approximately 17% between 2015 and 2022, primarily driven by Crohn’s disease and rheumatoid arthritis indications.
• Market share is constrained by competition from adalimumab and infliximab, with biosimilars expected to impact revenues from 2024 onward.
• Patent expiry in mid-2020s introduces risk, but expansion into new indications and orphan drug status could provide revenue buffers.
• Pricing strategies and reimbursement negotiations heavily influence financial outcomes amid increasing biosimilar entry.
• The COVID-19 pandemic and healthcare cost containment have heightened pressure on biologic pricing and adoption rates.

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FAQs

1. How does certolizumab pegol compare to other TNF inhibitors in terms of safety?

It does not contain an Fc region, which reduces placental transfer risk, making it suitable for pregnant women. Overall safety profiles are similar among TNFs.

2. When do key patents for certolizumab pegol expire?

Primary patents are scheduled to expire around 2024-2025, with secondary patents extending exclusivity to 2024.

3. What indications are currently approved for certolizumab pegol?

Approved for Crohn’s disease, rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis.

4. What are the main factors driving future revenue decline?

Biosimilar competition post-patent expiry, reimbursement restrictions, and market saturation.

5. Are biosimilars likely to be approved for certolizumab pegol?

Biosimilar versions are expected in the U.S. and Europe around 2024-2025, following patent expirations and regulatory pathways.

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References

1. U.S. Food and Drug Administration. (2009). Cimzia. https://www.fda.gov.
2. MarketsandMarkets. (2022). Biologic TNF inhibitors market analysis.
3. U.S. FDA. (2018). Certolizumab pegol pregnancy registry update.
4. EvaluatePharma. (2022). Biologics market share report.
5. UCB. (2022). Cimzia pricing and reimbursement information.
6. PatentData.org. (2022). Certolizumab pegol patent expiry timeline.

[1] FDA. (2009). Cimzia approval.
[2] MarketsandMarkets. (2022). Biologics market report.
[3] FDA. (2018). Pregnacy registry.
[4] EvaluatePharma. (2022). Market share analysis.
[5] UCB. (2022). Pricing and reimbursement report.
[6] PatentData.org. (2022). Patent expiry timeline.