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
NYU Langone Health	PHASE2
South Valley University	NA
Assistance Publique - Hôpitaux de Paris	Phase 3

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

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

International Patents for certolizumab pegol

Country	Patent Number	Estimated Expiration
Japan	2009171966
Portugal	2230308
Denmark	2230308
Norway	20131316

Supplementary Protection Certificates for certolizumab pegol

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
CA 2010 00010	Denmark
300982	Netherlands		PRODUCT NAME: CERTOLIZUMAB; REGISTRATION NO/DATE: EU/1/09/544/001-002 20091006
C300441	Netherlands		PRODUCT NAME: CERTOLIZUMAB PEGOL; REGISTRATION NO/DATE: EU/1/09/544/001-002 20091001
SPC022/2010	Ireland		SPC022/2010: 20110308, EXPIRES: 20240930

Market Dynamics and Financial Trajectory for the Biologic Drug: Certolizumab Pegol

Last updated: July 30, 2025

Introduction
Certolizumab pegol, marketed globally as Cimzia, is a tumor necrosis factor (TNF) inhibitor developed by UCB. Approved by the FDA in 2008, it is indicated for multiple inflammatory conditions, including rheumatoid arthritis (RA), Crohn’s disease, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. As a pegylated Fab fragment, it offers distinctive pharmacokinetics, including reduced placental transfer and a favorable dosing schedule, positioning it uniquely within the biologics market.

This article examines the market dynamics influencing certolizumab pegol and offers insights into its financial growth trajectory amid competitive, regulatory, and scientific factors.

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Market Landscape and Therapeutic Positioning
The biologic TNF inhibitors—specifically infliximab, adalimumab, etanercept, certolizumab pegol, and golimumab—dominate the autoimmune disease treatment landscape. Certolizumab pegol holds a niche advantage owing to its unique molecular structure and administration schedule. It is the only TNF inhibitor that does not contain an Fc region, reducing placental crossing—a crucial attribute for treating women of childbearing age.

The biologics market for inflammatory diseases is characterized by high growth driven by increasing prevalence rates, the advent of biosimilars, and expanding indications. The global biologics market for autoimmune diseases is projected to reach USD 420 billion by 2027, growing at a CAGR of 7% (Grand View Research, 2022)[1].

Certolizumab pegol’s therapeutic positioning as an effective option for patients with primary non-responsiveness or intolerance to other TNF agents bolsters its resilience amid intense competition.

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Market Drivers Influencing Certolizumab Pegol

1. Expanding Indications and Patient Demographics
   Certolizumab pegol’s approval extension to conditions such as psoriatic arthritis and axial spondyloarthritis has widened its target patient base. Elderly populations, increasingly affected by autoimmune conditions, further drive demand, especially as biologics offer superior efficacy over traditional therapies.

2. Pregnancy and Special Population Advantages
   Its minimal placental transfer positions certolizumab pegol as a preferred biologic for pregnant women with inflammatory diseases, a niche yet significant segment. This feature enhances its attractiveness among clinicians managing reproductive-aged women.

3. Pipeline and Combination Therapies
   Ongoing clinical trials exploring certolizumab pegol in combination with other agents, such as JAK inhibitors and biosimilars, may extend its indications and improve outcomes. Such developments likely bolster its market share and revenue potential.

4. Regulatory Approvals and Geographic Expansion
   Certolizumab pegol's approval in emerging markets, including Asia-Pacific and parts of Latin America, fuels revenue growth. The brand’s regulatory alignment with different authorities is a lever for global expansion.

5. Biologic Market Growth and Biosimilar Impact
   While biosimilars threaten the revenue streams of originator biologics, certolizumab pegol's unique structure and lack of biosimilar competitors as of 2023 provide a validation advantage, although competition is intensifying as biosimilars enter markets.

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Challenges and Competitive Dynamics

1. Intense Competition from Biosimilars
   The expiration of patents for other TNF agents, especially infliximab and adalimumab, has led to a surge in biosimilar options. While certolizumab pegol's patents are more recent, ongoing patent challenges and the threat of biosimilars remain significant. Market entrants like Amgen’s Avsola and Samsung’s Hadlima may influence pricing and market share.

2. Pricing Pressures and Reimbursement Policies
   In markets such as the US and Europe, reimbursement constraints and value-based pricing models exert downward pressure on biologic pricing. As new therapies enter, certolizumab pegol’s premium price point faces scrutiny.

3. Patient and Physician Preference Biases
   Despite its advantages, clinicians’ familiarity with other TNF inhibitors and entrenched prescribing habits may slow certolizumab pegol’s uptake. The need for more head-to-head comparative efficacy data remains.

4. Emerging Non-TNF Biologics and Small Molecules
   JAK inhibitors like baricitinib and upadacitinib present oral alternatives with comparable efficacy, challenging injectable TNF biologics' longevity. Their convenience and evolving safety profiles could divert patient demand.

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Financial Trajectory and Revenue Outlook

Historical Performance and Current Market Share
UCB’s revenue from certolizumab pegol has shown steady growth since its launch, with peak sales reaching approximately USD 1.4 billion in 2021 (UCB Annual Reports)[2]. Market penetration remains robust in RA and Crohn’s, with increasing uptake in newer indications.

Forecasted Growth
Analyst projections estimate a CAGR of 4–6% for certolizumab pegol over the next five years, driven by increasing global prevalence, expanded indications, and geographic expansion. However, this growth may be tempered by biosimilar competition and pricing pressures.

Potential Revenue Catalysts

• Expansion into underserved markets, such as Asia-Pacific and Africa.
• Use in pregnancy-sensitive populations, becoming a standard choice.
• Evidence emergence from ongoing clinical trials supporting broader or off-label uses.
• Strategic partnerships and licensing agreements with biosimilar manufacturers to extend reach.

Revenue Risks

• Patent litigations and exclusivity losses for key competitors.
• Entry of biosimilar versions of certolizumab pegol, which could erode market share.
• Healthcare policy reforms favoring cost-effectiveness and generic biologic uptake.

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Regulatory and Market Access Dynamics

Regulatory agencies prioritize safety and efficacy, but also increasingly favor cost-effective therapies. Certolizumab pegol’s favorable safety profile and unique reproductive benefits lend support to favorable coverage decisions in some regions.

Market access costs and reimbursement negotiations are critical, particularly in value-based care environments. UCB’s proven track record of engaging with payers will influence the drug’s financial trajectory.

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Conclusion
Certolizumab pegol’s market dynamics are shaped by its distinctive molecular structure, expanding therapeutic indications, and demographic trends favoring biologic therapies. While competition from biosimilars and emerging oral therapies pose challenges, its unique features offer sustained competitive advantages.

Financial growth prospects remain optimistic, contingent upon continued regulatory support, geographic expansion, and clinical validation. Strategic engagement with payers and investment in differentiated repositioning will be pivotal for maximizing revenue trajectories through 2023–2028.

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Key Takeaways

• Certolizumab pegol maintains a niche with its unique pharmacokinetics and safety profile, especially for women of reproductive age.
• The expanding global autoimmune biologics market supports sustained revenue growth, despite biosimilar competition.
• Geographic and indication expansion are vital for growth; emerging markets present significant opportunities.
• Pricing, reimbursement policies, and biosimilar entry will influence future profitability.
• Strategic clinical research and positioning can mitigate competition and reinforce certolizumab pegol’s market standing.

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FAQs

Q1: How does certolizumab pegol differ from other TNF inhibitors in terms of clinical efficacy?
A1: Certolizumab pegol demonstrates comparable efficacy to other TNF inhibitors in treating rheumatoid arthritis, Crohn’s disease, and psoriatic arthritis but offers advantages such as minimal placental crossing and a more flexible dosing schedule.

Q2: What are the patent challenges facing certolizumab pegol?
A2: UCB’s patent estate faces challenges from biosimilar applicants and patent litigation in key markets, which could potentially lead to biosimilar approval and market entry within the next five years.

Q3: What is the market outlook for certolizumab pegol in developing regions?
A3: Increasing healthcare infrastructure, unmet clinical needs, and favorable regulatory environments bolster the outlook, though pricing and reimbursement hurdles remain.

Q4: Are biosimilars a significant threat to certolizumab pegol?
A4: While biosimilars threaten incumbent biologics post-patent expiry, certolizumab pegol’s patent protections currently mitigate this threat. Future patent challenges may alter this landscape.

Q5: What upcoming clinical developments could impact certolizumab pegol’s market?
A5: Trials examining its use in additional indications, combination therapies, and pregnancy-related applications could expand its market footprint and revenue streams.

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References

[1] Grand View Research. (2022). Biologics Market Size & Trends.
[2] UCB Annual Report 2021.