AVASTIN Drug Profile

Summary for Tradename: AVASTIN

High Confidence Patents:	24
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for AVASTIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AVASTIN

Recent Clinical Trials for AVASTIN

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University of Miami	Phase 1/Phase 2
ImmunityBio, Inc.	Phase 2
Harbin Medical University	Phase 2

See all AVASTIN clinical trials

Recent Litigation for AVASTIN

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 AVASTIN 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 AVASTIN litigation

Pharmacology for AVASTIN

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 AVASTIN 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		2035-07-31
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	February 26, 2004		2028-07-08
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	February 26, 2004		2028-07-08

2) High Certainty: US Patents for AVASTIN 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 AVASTIN 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

International Patents for AVASTIN

Country	Patent Number	Estimated Expiration
Denmark	0804237
European Patent Office	0921815
Japan	2006045237

Supplementary Protection Certificates for AVASTIN

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
06C0024	France		PRODUCT NAME: NATALIZUMAB,ANTICORPS MONOCLONAL HUMANISE ANTI-INTEGRINE ALPHA-4; REGISTRATION NO/DATE: EU/1/06/346/001 20060627
132006901471186	Italy		PRODUCT NAME: NATALIZUMAB(TYSABRI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/06/346/001, 20060627
2006C/035	Belgium		PRODUCT NAME: NATALIZUMAB; AUTHORISATION NUMBER AND DATE: EU/1/06/346/001 20060628

AVASTIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: Avastin

Introduction

Avastin, also known as bevacizumab, is a biologic drug used primarily in the treatment of various types of cancer, including colorectal, lung, and breast cancer. Developed by Genentech (a member of the Roche Group), Avastin has been a cornerstone in cancer therapy for over two decades. However, the market dynamics and financial trajectory of Avastin have undergone significant changes with the emergence of biosimilars.

Historical Market Performance

Historically, Avastin has been a high-revenue generator for Roche. In 2022, sales of Avastin, along with other blockbuster drugs like MabThera/Rituxan and Herceptin, contributed significantly to Roche's pharmaceutical division revenues. However, these sales have been impacted by the increasing competition from biosimilars.

Impact of Biosimilar Competition

The expiration of patents for Avastin has led to the entry of biosimilars into the market. Biosimilars are biologic drugs that are highly similar to the original biologic drug but are typically cheaper. This competition has resulted in a decline in Avastin's sales. For instance, in 2023, sales of Avastin decreased by a combined CHF 1.1 billion (or 17%) at constant exchange rates (CER) due to biosimilar competition[2].

Current Market Size and Growth

The bevacizumab biosimilars market, which directly affects Avastin's sales, has grown strongly in recent years. In 2023, the market size was $1.43 billion, and it is expected to grow to $1.55 billion in 2024 at a compound annual growth rate (CAGR) of 8.7%. By 2028, the market is projected to reach $2.09 billion with a CAGR of 7.8%[1][5].

Drivers of Market Growth

Several factors are driving the growth of the bevacizumab biosimilars market, and consequently, influencing Avastin's financial trajectory:

Rising Demand for Cancer Therapies

The increasing incidence of cancer is a significant driver. For example, reports from Macmillan Cancer Support indicate an anticipated increase in cancer patients from 3 million in 2020 to 5.3 million by 2040[5].

Cost Containment in Healthcare

Healthcare systems are under pressure to reduce costs, making biosimilars an attractive option due to their lower prices compared to the original biologic drugs.

Biosimilar Development Expertise

Pharmaceutical companies are investing heavily in developing biosimilars to capitalize on the market opportunity. Companies like Amgen have developed biosimilars for several biologic drugs, including bevacizumab[4].

Regulatory Advancements

Evolving regulatory landscapes and approvals are facilitating the entry of more biosimilars into the market. This includes considerations of biosimilar interchangeability, which further increases market competition[1][5].

Financial Impact on Roche

The financial impact of biosimilar competition on Roche is evident in their recent financial reports. While the Pharmaceuticals Division of Roche saw an increase in operating profit driven by new products like Vabysmo, Ocrevus, and Hemlibra, the sales of Avastin and other older biologics decreased significantly. In 2023, the sales of Avastin and other biologics like MabThera/Rituxan and Herceptin declined by CHF 1.1 billion due to biosimilar competition[2].

Market Strategies and Trends

To mitigate the impact of biosimilar competition, pharmaceutical companies are adopting several strategies:

Collaborations and Partnerships

Companies are engaging in collaborations and partnerships to develop new products and expand their market reach. For example, Sutro Biopharma's collaborations with Astellas and Vaxcyte have contributed significantly to their revenue growth[3].

Regulatory Advancements

Regulatory advancements and approvals are crucial for the entry of new biosimilars. Companies are focusing on obtaining approvals and ensuring regulatory compliance to stay competitive[1][5].

Market Access Strategies

Effective market access strategies, including pricing and reimbursement policies, are being implemented to ensure that biosimilars are accessible to a wider patient population[1].

Lifecycle Management

Pharmaceutical companies are also focusing on lifecycle management of their products, including the development of new indications and formulations to extend the product's market life[1].

Future Outlook

The future outlook for Avastin and the bevacizumab biosimilars market is marked by continued growth driven by the increasing demand for cancer therapies and the expanding healthcare expenditure. However, the competition from biosimilars is expected to remain a significant challenge.

Increasing Prevalence of Cancer

The anticipated increase in cancer cases will drive the demand for bevacizumab and its biosimilars. This trend is expected to continue, with cancer patient numbers projected to rise significantly by 2040[5].

Healthcare Expenditure

The growth in healthcare expenditure, particularly in the United States, is expected to support the expansion of the bevacizumab biosimilars market. Healthcare spending in the U.S. increased by 2.7% to $4.3 trillion in 2021, and this trend is likely to continue[5].

Key Takeaways

• The bevacizumab biosimilars market is growing strongly, driven by patent expirations, cost containment, and rising cancer rates.
• Avastin's sales have declined due to biosimilar competition, impacting Roche's pharmaceutical division revenues.
• Regulatory advancements, collaborations, and effective lifecycle management are key strategies for pharmaceutical companies to navigate the biosimilar market.
• The increasing prevalence of cancer and growing healthcare expenditure will continue to drive the demand for bevacizumab and its biosimilars.

FAQs

What is the current market size of the bevacizumab biosimilars market?

The bevacizumab biosimilars market size was $1.43 billion in 2023 and is expected to grow to $1.55 billion in 2024[1][5].

How is the increasing prevalence of cancer affecting the bevacizumab biosimilars market?

The increasing prevalence of cancer is driving the demand for bevacizumab and its biosimilars. Cancer patient numbers are projected to rise significantly by 2040, which will continue to drive market growth[5].

What strategies are pharmaceutical companies using to mitigate the impact of biosimilar competition?

Pharmaceutical companies are engaging in collaborations, regulatory advancements, market access strategies, and lifecycle management to mitigate the impact of biosimilar competition[1][5].

How has biosimilar competition affected Avastin's sales?

Biosimilar competition has resulted in a significant decline in Avastin's sales. In 2023, sales of Avastin decreased by CHF 1.1 billion due to biosimilar competition[2].

What is the projected growth rate of the bevacizumab biosimilars market by 2028?

The bevacizumab biosimilars market is expected to grow to $2.09 billion by 2028 at a CAGR of 7.8%[1][5].

Sources

1. The Business Research Company, "Global Bevacizumab Biosimilars Market Report 2024".
2. Roche, "Finance Report 2023".
3. Sutro Biopharma, "Second Quarter 2024 Financial Results".
4. CAS.org, "The Rise of Biologics: Emerging Trends and Opportunities".
5. GlobeNewswire, "Global Bevacizumab Biosimilars Market Outlook 2024-2028 & 2033".