Bevacizumab - Biologic Drug Details

Summary for bevacizumab

Tradenames:	1
High Confidence Patents:	24
Applicants:	6
BLAs:	6
Suppliers: see list	6
Recent Clinical Trials:	See clinical trials for bevacizumab
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for bevacizumab

Recent Clinical Trials for bevacizumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University of Miami	Phase 1/Phase 2
Nykode Therapeutics ASA	Phase 2
University of Nebraska	Phase 1

See all bevacizumab clinical trials

Recent Litigation for bevacizumab

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
GENENTECH, INC. v. DR. REDDYS LABORATORIES, INC.	2023-11-17
Taiho Pharmaceutical Co., Ltd. v. Eugia Pharma Specialities Ltd.	2023-10-20
Genentech, Inc. v. Biogen MA Inc.	2023-07-13

See all bevacizumab 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 bevacizumab litigation

Pharmacology for bevacizumab

Mechanism of Action	Vascular Endothelial Growth Factor Inhibitors Vascular Endothelial Growth Factor-directed Antibody Interactions
Established Pharmacologic Class	Vascular Endothelial Growth Factor Inhibitor

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 bevacizumab Derived from Brand-Side Litigation

These patents were obtained from brand-side disclosures in response to biosimilar applications

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Patent Expiration
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	February 26, 2004		2028-07-08
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	February 26, 2004		2034-03-14
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	February 26, 2004		2030-08-06
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	February 26, 2004		2034-03-14
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	February 26, 2004		2025-03-08
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	February 26, 2004		2031-08-18
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	February 26, 2004		2024-05-28

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085		2014-01-25	Company disclosures
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085		2020-08-05	Company disclosures

3) Low Certainty: US Patents for bevacizumab 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
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085		2035-03-27	Patent claims search
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085		2032-09-12	Patent claims search
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085		2035-12-11	Patent claims search
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085		2034-02-06	Patent claims search
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085		2035-03-30	Patent claims search
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085		2033-03-13	Patent claims search
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085		2034-09-29	Patent claims search

International Patents for bevacizumab

Country	Patent Number	Estimated Expiration
Japan	H08507680
Hungary	9602019
France	06C0024
Spain	2137354
Australia	1696095
South Korea	100367948
Denmark	1759709

Supplementary Protection Certificates for bevacizumab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
300238	Netherlands		PRODUCT NAME: NATALIZUMAB; REGISTRATION NO/DATE: EU/1/06/346/001 20060630
2006C/035	Belgium		PRODUCT NAME: NATALIZUMAB; AUTHORISATION NUMBER AND DATE: EU/1/06/346/001 20060628
91271	Luxembourg		PRODUCT NAME: NATALIZUMAB ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES ( TYSABRI ); AUTHORISATION NUMBER AND DATE: EU/1/06/346/001
SPC 025/2006	Ireland		SPC 025/2006: 20070523, EXPIRES: 20200124
23/2006	Austria		PRODUCT NAME: NATALIZUMAB; REGISTRATION NO/DATE: EU/1/06/346/001 20060627
C00804237/01	Switzerland		FORMER OWNER: ELAN PHARMACEUTICALS, INC., US
06C0024	France		PRODUCT NAME: NATALIZUMAB,ANTICORPS MONOCLONAL HUMANISE ANTI-INTEGRINE ALPHA-4; REGISTRATION NO/DATE: EU/1/06/346/001 20060627

Market Dynamics and Financial Trajectory for Bevacizumab Biosimilars

Introduction

Bevacizumab, a monoclonal antibody used primarily in the treatment of various types of cancer, has seen significant growth in its biosimilars market. This article delves into the market dynamics and financial trajectory of bevacizumab biosimilars, highlighting key drivers, trends, and projections.

Market Size and Growth

The bevacizumab biosimilars market has experienced robust growth in recent years. As of 2023, the market size was valued at $1.43 billion and is expected to grow to $1.55 billion in 2024, with a compound annual growth rate (CAGR) of 8.7%[1][3].

By 2028, the market is projected to reach $2.09 billion, maintaining a CAGR of 7.8%. This growth is driven by several key factors, including the rising demand for cancer therapies, advancements in biosimilar development, and increasing healthcare system pressures[1][3].

Key Drivers of Growth

Patent Expiry and Cost Containment

The expiry of patents for the original bevacizumab has opened the market for biosimilars, allowing for more affordable treatment options. This, combined with cost containment efforts in healthcare, has significantly boosted the adoption of bevacizumab biosimilars[1][3].

Increasing Incidence of Cancer

The anticipated increase in cancer cases is a major driver for the market. For instance, reports from Macmillan Cancer Support indicate an expected rise in cancer patients from 3 million in 2020 to 5.3 million by 2040[3].

Market Competitiveness and Patient Access

The market is becoming increasingly competitive, with multiple players entering the biosimilars space. This competition, along with improved patient access and affordability, has enhanced the market's growth potential[1][3].

Regulatory Landscape

Advancements in regulatory frameworks and approvals are facilitating the entry of new biosimilars into the market. The evolving biosimilar regulatory landscape, including considerations of interchangeability, is also a significant factor[1][3].

Major Trends

Collaborations and Partnerships

Collaborations between pharmaceutical companies and biotechnology firms are on the rise, driving innovation and development in the biosimilars sector. These partnerships are crucial for accelerating the launch of new biosimilars[1][3].

Regulatory Advancements

Regulatory bodies are increasingly supportive of biosimilars, with clearer guidelines and faster approval processes. This has encouraged more companies to invest in biosimilar development[1][3].

Biosimilar Development and Innovation

Continuous innovation in biosimilar development is a key trend. Companies are focusing on improving manufacturing processes, reducing costs, and enhancing the efficacy of biosimilars[1][3].

Market Access Strategies

Effective market access strategies are critical for the success of biosimilars. Companies are developing comprehensive strategies to ensure widespread availability and adoption of their products[1][3].

Lifecycle Management

Biosimilar lifecycle management is becoming more sophisticated, with companies focusing on extending the life of their products through various strategies such as label expansions and combination therapies[1][3].

Financial Impact

Cost Savings

The adoption of bevacizumab biosimilars has significant financial implications. Studies have shown that switching to biosimilars can result in substantial cost savings. For example, a hypothetical financial analysis model estimated 5-year cost savings of $7,030,924 for commercial payers and $4,059,257 for Medicare[5].

Purchase Price and Administrative Costs

The average wholesale acquisition price of biosimilars is lower than that of the original drug, leading to direct cost savings. However, other costs such as administrative fees, medication infusion, and ancillary medications are also important considerations[5].

Regional Market Dynamics

North America

North America, particularly the U.S. and Canada, accounts for a significant share of the global bevacizumab market. The region's well-established medical infrastructure and high incidence of cancer drive the demand for bevacizumab and its biosimilars[4].

International Growth

International sales, especially in regions outside the European Union, are also growing. For instance, Servier's international revenue, particularly in the U.S., has seen significant increases, contributing to the overall growth of the biosimilars market[2].

Real-World Tolerability and Safety

Comparative Studies

Studies comparing the safety profiles of bevacizumab and its biosimilars have shown similar outcomes in terms of adverse effects such as hypertension, proteinuria, severe hemorrhage, and gastrointestinal perforation. This similarity in safety profiles further supports the adoption of biosimilars[5].

Future Outlook

The bevacizumab biosimilars market is poised for continued growth driven by increasing cancer prevalence, advancements in healthcare expenditure, and favorable regulatory environments. Here are some key points to consider:

• Rising Cancer Prevalence: The anticipated increase in cancer cases will drive the demand for bevacizumab and its biosimilars.
• Healthcare Expenditure: Growing healthcare spending, particularly in the U.S., will support the expansion of the biosimilars market.
• Regulatory Support: Evolving regulatory landscapes and increasing acceptance of biosimilars will facilitate market growth.
• Innovation and Development: Continuous innovation in biosimilar development will improve efficacy and reduce costs.

Key Takeaways

• The bevacizumab biosimilars market is expected to grow from $1.43 billion in 2023 to $2.09 billion by 2028.
• Key drivers include patent expiry, cost containment, rising cancer incidence, and regulatory advancements.
• Collaborations, regulatory support, and lifecycle management are major trends.
• Significant cost savings can be achieved through the adoption of biosimilars.
• North America and international markets are key regions driving growth.

FAQs

Q: What is the current market size of bevacizumab biosimilars? A: The current market size of bevacizumab biosimilars is $1.43 billion as of 2023[1][3].

Q: What is the projected growth rate of the bevacizumab biosimilars market? A: The market is expected to grow at a CAGR of 7.8% from 2023 to 2028[1][3].

Q: What are the main drivers of the bevacizumab biosimilars market? A: The main drivers include patent expiry, cost containment, increasing cancer incidence, market competitiveness, and regulatory advancements[1][3].

Q: How do bevacizumab biosimilars compare in terms of safety and efficacy to the original drug? A: Studies have shown that bevacizumab biosimilars have a similar safety profile to the original drug, with comparable adverse effects[5].

Q: What are the financial benefits of adopting bevacizumab biosimilars? A: Adopting bevacizumab biosimilars can result in significant cost savings, with estimated 5-year savings ranging from $4 million to $7 million depending on the payer type[5].

Sources

1. The Business Research Company, "Global Bevacizumab Biosimilars Market Report 2024".
2. Servier, "Servier confirms its 2025 trajectory to achieve its 2030 ambition".
3. GlobeNewswire, "Global Bevacizumab Biosimilars Market Outlook 2024-2028 & 2033".
4. Fortune Business Insights, "Bevacizumab Market Size, Share, Trends By Forecast till 2032".
5. Journal of Hematology Oncology Pharmacy, "Real-World Tolerability and Financial Impact of Biosimilar Bevacizumab".

Last updated: 2024-12-16