Cetuximab - Biologic Drug Details

Summary for cetuximab

Tradenames:	1
High Confidence Patents:	1
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for cetuximab
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cetuximab

Recent Clinical Trials for cetuximab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University of Miami	Phase 1/Phase 2
Peking University	N/A
BioMed Valley Discoveries, Inc	Phase 1

See all cetuximab clinical trials

Recent Litigation for cetuximab

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Taiho Pharmaceutical Co., Ltd. v. Eugia Pharma Specialities Ltd.	2023-10-20
Janssen Biotech, Inc. v. Amgen Inc.	2022-11-29
Ravgen, Inc. v. Quest Diagnostics Incorporated	2021-11-17

See all cetuximab litigation

PTAB Litigation

Petitioner	Date
Illumina, Inc. et al.	2021-07-20
Laboratory Corporation of America Holdings et al.	2021-05-28
Quest Diagnostics Incorporated	2021-04-15

See all cetuximab litigation

Pharmacology for cetuximab

Mechanism of Action	HER1 Antagonists
Established Pharmacologic Class	Epidermal Growth Factor Receptor 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. General 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 cetuximab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for cetuximab Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084		2018-04-17	Company disclosures

3) Low Certainty: US Patents for cetuximab 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
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084		2032-09-12	Patent claims search
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084		2034-09-08	Patent claims search
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084		2033-03-11	Patent claims search
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084		2039-02-26	Patent claims search

International Patents for cetuximab

Country	Patent Number	Estimated Expiration
Germany	68922808
Luxembourg	91449
Netherlands	300350
Spain	2174859

Supplementary Protection Certificates for cetuximab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
122008000028	Germany		PRODUCT NAME: PANITUMUMAB MIT EINEM ANTINEOPLASTISCHEN WIRKSTOFF, INSBESONDERE PANITUMUMAB MIT EINEM ODER MEHREREN DER FOLGENDEN 1 BIS 22: 1 IRINOTECAN 2 CISPLATIN 3 5-FLUORURACIL 4 FOLINSAEURE 5 CISPNSAEURE, 5-FLUORURACIL UND IRINOTECAN =FOLFIRI 9 FOLINSAEURE, 5-FLUORURACIL UND OXALI; REGISTRATION LATIN UND/ODER DOCETAXEL 6 OXALIPLATIN UND/ODER CAPECITABIN 7 IRINOTECAN UND/ODER CYCLOSPORIN 8 FOLINO/DATE: EU/1/07/423/001-003 20071203
122008000030	Germany		PRODUCT NAME: PANITUMUMAB MIT WENIGSTENS EINEM WIRKSTOFF AUSGEWAEHLT AUS IRINOTECAN, CISPLATIN, 5-FLUOROURACIL, GEMCITABIN, PACLITAXEL UND CARBOPLATIN; REGISTRATION NO/DATE: EU/1/07/423/001-003 20071203
122004000040	Germany		PRODUCT NAME: CETUXIMAB IN KOMBINATION MIT IRINOTECAN; REGISTRATION NO/DATE: EU/1/04/281/001 20040629
91116	Luxembourg		91116, EXPIRES: 20140915

Market Dynamics and Financial Trajectory for the Biologic Drug: Cetuximab

Market Overview

Cetuximab, marketed under the brand name Erbitux, is a chimeric monoclonal antibody used to treat head and neck cancer and metastatic colorectal cancer. It works by inhibiting the epidermal growth factor receptor (EGFR), thereby slowing the growth of cancer cells. Here’s a detailed look at the market dynamics and financial trajectory of cetuximab.

Market Size and Forecast

The cetuximab market is projected to grow significantly over the coming years. As of 2023, the market size was valued at USD 98.5 billion and is expected to reach USD 121.3 billion by 2031, growing at a compound annual growth rate (CAGR) of 2.64% from 2024 to 2031[3].

Regional Market Analysis

North America

North America dominates the cetuximab market, holding more than 49% of the market share. This dominance is attributed to the high incidence of cancer, advanced healthcare infrastructure, and significant investments in cancer research and development in this region[1].

Europe

Europe is the second-largest market for cetuximab, driven by supportive healthcare policies, an aging population, and an increasing number of cancer patients. European countries have robust funding structures to encourage the use of new cancer treatments[1].

Asia Pacific

The Asia Pacific region is expected to be the fastest-growing segment during the forecast period. Increased healthcare spending, particularly in China and India, and growing awareness about cancer and targeted therapies are key drivers in this region[1].

Market Drivers

Several factors are propelling the growth of the cetuximab market:

Increasing Cancer Incidence

The rising incidence of cancer globally, especially in regions like North America and Europe, is a primary driver. The need for efficient treatments is urgent, given the high impact of cancer on these populations[1].

Advances in Biotechnology

Continuous research and advancements in biotechnology are improving the efficacy of cetuximab and expanding its therapeutic uses. Clinical trials demonstrating its effectiveness in new settings or populations further drive demand[3].

Government Initiatives and Healthcare Infrastructure

Government initiatives supporting cancer research and treatment, along with the development of healthcare infrastructure in emerging markets, are crucial for the market's growth. Improved access to cancer treatment in regions like Asia Pacific is also a significant factor[1][3].

Patient Preference for Targeted Therapies

Patients increasingly prefer targeted medications like cetuximab over traditional chemotherapy due to their specificity and reduced side effects. This preference, combined with increased awareness through screening programs, contributes to market growth[1].

Economic and Financial Aspects

Cost-Effectiveness Analysis

Despite its clinical benefits, cetuximab's cost-effectiveness is a significant concern. A study in China showed that the incremental cost-effectiveness ratio (ICER) for cetuximab combined with FOLFOX-4 was approximately $164,044 per quality-adjusted life year (QALY), which is far beyond the willingness-to-pay threshold[2].

Pricing and Reimbursement

The cost of cetuximab and its pricing relative to other therapies significantly impact market dynamics. Pricing strategies, reimbursement policies, and economic factors influencing drug affordability play a crucial role. For instance, 18 weeks of cetuximab treatment for non-small cell lung cancer can cost around $80,000 in the United States[5].

Biosimilars and Competition

The expiration of patent protection for cetuximab in Europe, the US, and Japan has led to the development of biosimilars, which will increase market competition and potentially reduce costs. This competition can impact the market share and pricing of cetuximab[4].

Regulatory and Market Access Challenges

Regulatory Approvals

Obtaining and maintaining regulatory approvals in various markets can be complex and time-consuming. Changes in regulatory requirements or delays in approvals can affect market availability[3].

Reimbursement Issues

Reimbursement policies vary by country and healthcare system, and in some regions, reimbursement for cetuximab may be limited or subject to stringent conditions, affecting its uptake[3].

Key Market Players

The cetuximab market is dominated by a few large companies, including:

• Eli Lilly and Company: Responsible for the manufacturing and distribution of cetuximab as Erbitux in the US and Canada.
• Merck Group: Manufactures and supplies cetuximab outside the US and Canada territory[1][4].

Market Dynamics and Competitive Landscape

The oncology market is highly competitive, with numerous alternative therapies available, including other monoclonal antibodies and targeted therapies. The emergence of new treatments and biosimilars can impact cetuximab’s market share and pricing. Effective marketing strategies by pharmaceutical companies, such as physician education and patient awareness campaigns, also influence the adoption of cetuximab[3].

Future Outlook

The future of the cetuximab market looks promising, driven by ongoing research to improve its efficacy, reduce side effects, and discover new therapeutic uses. The development of healthcare infrastructure in emerging markets and the increasing awareness about targeted therapies will continue to drive demand. However, the market will need to navigate challenges related to cost-effectiveness, regulatory approvals, and reimbursement policies to sustain growth.

Key Takeaways

• The cetuximab market is projected to grow at a CAGR of 2.64% from 2024 to 2031.
• North America dominates the market, followed by Europe and the Asia Pacific.
• Increasing cancer incidence, advances in biotechnology, and government initiatives are key drivers.
• Cost-effectiveness and reimbursement issues are significant challenges.
• Biosimilars and competitive therapies will impact market dynamics.
• Eli Lilly and Company and Merck Group are the major players in the market.

FAQs

Q: What is cetuximab used for?

Cetuximab is used to treat head and neck cancer and metastatic colorectal cancer by inhibiting the epidermal growth factor receptor (EGFR).

Q: What is the projected market size of cetuximab by 2031?

The cetuximab market is projected to reach USD 121.3 billion by 2031, growing at a CAGR of 2.64% from 2024 to 2031[3].

Q: Which regions dominate the cetuximab market?

North America dominates the market, followed by Europe and the Asia Pacific region[1].

Q: What are the main challenges facing the cetuximab market?

The main challenges include cost-effectiveness issues, regulatory approvals, reimbursement policies, and competition from biosimilars and other targeted therapies[2][3].

Q: Who are the key players in the cetuximab market?

The key players are Eli Lilly and Company and Merck Group[1][4].

Sources

1. We Market Research: Cetuximab Market Size, Trends, Growth, Segmentation & Forecast to 2034.
2. BMJ Open: Cost-effectiveness analysis of cetuximab combined with FOLFOX-4.
3. Verified Market Research: Cetuximab Market Size, Share, Trends & Forecast.
4. Reports and Data: Global Cetuximab Market Size & Value | Industry Analysis, 2019-2026.
5. Journal of the National Cancer Institute: How Much Is Life Worth: Cetuximab, Non–Small Cell Lung Cancer, and the $100,000-per-Month Question.