CLINICAL TRIALS PROFILE FOR AVASTIN

Biosimilar Clinical Trials for AVASTIN

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02069704 ↗	Bioequivalence Study Bevacizumab Biosimilar (BEVZ92) Versus Bevacizumab (AVASTIN®) in First-line Treatment mCRC Patients	Completed	Laboratorio Elea Phoenix S.A.	Phase 1	2014-10-29	This is a multicenter, open label, randomized bioequivalence study of BEVZ92 (bevacizumab biosimilar) and Avastin® with 2 parallel arms to compare the pharmacokinetic (PK) profile of BEVZ92 and Avastin® in combination with FOLFOX (any) or FOLFIRI chemotherapy. FOLFOX (any) or FOLFIRI will be chosen as per investigator criteria based on the hospital standard of care.
NCT02069704 ↗	Bioequivalence Study Bevacizumab Biosimilar (BEVZ92) Versus Bevacizumab (AVASTIN®) in First-line Treatment mCRC Patients	Completed	Laboratorio Elea S.A.C.I.F. y A.	Phase 1	2014-10-29	This is a multicenter, open label, randomized bioequivalence study of BEVZ92 (bevacizumab biosimilar) and Avastin® with 2 parallel arms to compare the pharmacokinetic (PK) profile of BEVZ92 and Avastin® in combination with FOLFOX (any) or FOLFIRI chemotherapy. FOLFOX (any) or FOLFIRI will be chosen as per investigator criteria based on the hospital standard of care.
NCT02069704 ↗	Bioequivalence Study Bevacizumab Biosimilar (BEVZ92) Versus Bevacizumab (AVASTIN®) in First-line Treatment mCRC Patients	Completed	Libbs Farmacêutica LTDA	Phase 1	2014-10-29	This is a multicenter, open label, randomized bioequivalence study of BEVZ92 (bevacizumab biosimilar) and Avastin® with 2 parallel arms to compare the pharmacokinetic (PK) profile of BEVZ92 and Avastin® in combination with FOLFOX (any) or FOLFIRI chemotherapy. FOLFOX (any) or FOLFIRI will be chosen as per investigator criteria based on the hospital standard of care.
NCT02069704 ↗	Bioequivalence Study Bevacizumab Biosimilar (BEVZ92) Versus Bevacizumab (AVASTIN®) in First-line Treatment mCRC Patients	Completed	mAbxience S.A	Phase 1	2014-10-29	This is a multicenter, open label, randomized bioequivalence study of BEVZ92 (bevacizumab biosimilar) and Avastin® with 2 parallel arms to compare the pharmacokinetic (PK) profile of BEVZ92 and Avastin® in combination with FOLFOX (any) or FOLFIRI chemotherapy. FOLFOX (any) or FOLFIRI will be chosen as per investigator criteria based on the hospital standard of care.
NCT02450981 ↗	Evaluation the Pharmacokinetics, Safety, Tolerability of BCD-021 in Patients With Neovascular Age-related Macular Degeneration	Withdrawn	Biocad	Phase 1	1969-12-31	This clinical study is a phase 1 study which carried out to to evaluate the safety, pharmacokinetics and tolerability of multiple intravitreal injections of BCD-021(bevacizumab biosimilar candidate manufactured by CJSC BIOCAD, Russia) when used in patients with neovascular wet age-related macular degeneration.
NCT02754882 ↗	A Study Comparing SB8 and Avastin® in Patients With Advanced Non-squamous Non-small Cell Lung Cancer	Completed	Samsung Bioepis Co., Ltd.	Phase 3	2016-07-05	This study is designed to establish biosimilarity of SB8, a proposed biosimilar product of bevacizumab, to EU-sourced bevacizumab, in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).

All Clinical Trials for AVASTIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00016107 ↗	Combination Chemotherapy Plus Bevacizumab in Treating Patients With Metastatic Prostate Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2001-06-01	Phase II trial to study the effectiveness of combination chemotherapy plus monoclonal antibody therapy in treating patients who have metastatic prostate cancer that has not responded to previous hormone therapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab may stop the growth of cancer cells by stopping blood flow to the tumor. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.
NCT00017394 ↗	Bevacizumab Plus Vinorelbine in Treating Patients With Stage IV Breast Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2001-03-01	Phase II trial to study the effectiveness of bevacizumab combined with vinorelbine in treating patients who have stage IV breast cancer. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody with chemotherapy may kill more cancer cells
NCT00021060 ↗	Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer	Completed	National Cancer Institute (NCI)	Phase 2/Phase 3	2002-08-01	Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining chemotherapy with a monoclonal antibody may kill more tumor cells. This randomized phase II/III trial is to see if combination chemotherapy works better with or without bevacizumab in treating patients who have advanced, metastatic, or recurrent non-small cell lung cance
NCT00023920 ↗	Bevacizumab, Idarubicin, and Cytarabine in Treating Patients With Blast Phase Chronic Myelogenous Leukemia	Terminated	National Cancer Institute (NCI)	Phase 2	2001-07-01	This phase II trial is to see if combining bevacizumab with idarubicin and cytarabine works better in treating patients who have blast phase chronic myelogenous leukemia. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may be an effective treatment for blast phase chronic myelogenous leukemia
NCT00023959 ↗	Bevacizumab, Fluorouracil, and Hydroxyurea Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer	Completed	National Cancer Institute (NCI)	Phase 1	2001-07-01	Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining monoclonal antibody therapy with chemotherapy and radiation therapy may be an effective treatment for head and neck cancer. This phase I trial is to see if combining bevacizumab, fluorouracil, and hydroxyurea with radiation therapy works in treating patients who have advanced head and neck cancer
NCT00025337 ↗	Combination Chemotherapy With or Without Bevacizumab Compared With Bevacizumab Alone in Treating Patients With Advanced or Metastatic Colorectal Cancer That Has Been Previously Treated	Completed	National Cancer Institute (NCI)	Phase 3	2001-09-01	Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without bevacizumab in treating patients who have advanced or metastatic colorectal cancer that has been previously treated. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with combination chemotherapy may kill more tumor cells. It is not yet known if bevacizumab is more effective with or without combination chemotherapy in treating colorectal cancer

Clinical Trial Conditions for AVASTIN

Condition Name

Condition Name for AVASTIN
Intervention	Trials
Colorectal Cancer	94
Breast Cancer	82
Glioblastoma	46
Ovarian Cancer	43

Condition MeSH

Condition MeSH for AVASTIN
Intervention	Trials
Colorectal Neoplasms	188
Carcinoma	148
Carcinoma, Non-Small-Cell Lung	128
Breast Neoplasms	121

Clinical Trial Locations for AVASTIN

Trials by Country

Trials by Country for AVASTIN
Location	Trials
Spain	283
Italy	276
Canada	256
Australia	122
Brazil	108

Trials by US State

Trials by US State for AVASTIN
Location	Trials
Texas	222
California	216
Ohio	179
Florida	175
New York	169

Clinical Trial Progress for AVASTIN

Clinical Trial Phase

Clinical Trial Phase for AVASTIN
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	1
PHASE1	3

Clinical Trial Status

Clinical Trial Status for AVASTIN
Clinical Trial Phase	Trials
Completed	663
Terminated	144
Recruiting	110

Clinical Trial Sponsors for AVASTIN

Sponsor Name

Sponsor Name for AVASTIN
Sponsor	Trials
Genentech, Inc.	218
National Cancer Institute (NCI)	189
Hoffmann-La Roche	149

Sponsor Type

Sponsor Type for AVASTIN
Sponsor	Trials
Other	1189
Industry	769
NIH	200

Clinical Trials Update, Market Analysis, and Projection for Avastin (Bevacizumab)

Last updated: October 26, 2025

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Introduction

Avastin (bevacizumab), developed by Genentech/Roche, remains one of the most prominently used monoclonal antibodies in oncology. Since its initial FDA approval in 2004, Avastin has transformed cancer treatment paradigms through its anti-angiogenic mechanism, targeting vascular endothelial growth factor A (VEGF-A). This review offers a comprehensive analysis of recent clinical trial developments, market performance, and future projections for Avastin, emphasizing how emerging data and competitive dynamics influence its global value proposition.

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Recent Clinical Trials and Evolving Indications

Ongoing and Recent Trials

In the last 12-24 months, Avastin's clinical development portfolio has concentrated on expanding its therapeutic scope and optimizing existing indications:

• Glioblastoma Multiforme (GBM): Multiple studies, including phase III trials, have evaluated Avastin's efficacy in recurrent GBM. Despite some trials showing symptomatic improvements, recent data indicates marginal overall survival benefits, influencing regulatory and clinical decision-making. Notably, the BELOB trial highlighted that combining Avastin with other agents, such as lomustine, does not consistently extend survival substantially in GBM.

• Non-Small Cell Lung Cancer (NSCLC): Current trials assess Avastin in combination with emerging immunotherapies like PD-1 inhibitors. Early phase studies suggest a potential synergistic effect, but definitive evidence awaits larger randomized controlled trials (RCTs).

• Ovarian and Fallopian Tube Cancers: Additional trials are examining Avastin as part of maintenance therapy post-chemotherapy, with recent data indicating improvements in progression-free survival (PFS), though overall survival (OS) benefits remain contentious.

• Intravitreal Use in Age-Related Macular Degeneration (AMD): Although not a primary oncology focus, Avastin's off-label application in AMD continues, with ongoing trials assessing optimal dosing schedules to minimize adverse effects.

Regulatory and Label Updates

• FDA Label Changes: Recent updates reflect the approval of Avastin in combination with chemotherapy for metastatic colorectal cancer, non-squamous NSCLC, and certain breast cancers. Nevertheless, the FDA has revoked or restricted some indications, notably metastatic breast cancer, citing lack of survival benefit and safety concerns. The European Medicines Agency (EMA) maintains broader indications but emphasizes careful patient selection.

• Emerging Biomarkers: Studies are investigating predictive biomarkers for response, like circulating VEGF levels and tumor VEGF expression, with prospects for personalized therapy strategies.

Market Dynamics and Commercial Performance

Market Size and Launches

As of 2022, Avastin commands a significant presence in the global oncology therapeutics market:

• Market Valuation: The global anti-VEGF oncology market, driven primarily by Avastin, was valued at approximately USD 7 billion in 2022 and projected to reach USD 10 billion by 2026, with a CAGR of approximately 8%[1].

• Key Regions: North America remains the largest market, accounting for nearly 55% of Avastin's revenue, followed by Europe and Asia-Pacific, with rising adoption correlating with expanding indications and increasing cancer prevalence.

Competitive Landscape

• Generic Biosimilars: The entry of biosimilars, such as SohyBio’s SB8 (approved in Europe and other markets), has significantly eroded Avastin’s market share[2]. These biosimilars offer comparable efficacy at lower costs, impacting revenue streams.

• Alternative Anti-angiogenics: Competitors like Amgen’s Vectibix and Regeneron's Zaltrap are challenging Avastin in colorectal and other cancers, though Avastin retains a broad label and established position.

• Immunotherapy Combination Trials: Growing interest in combining Avastin with agents like pembrolizumab (Keytruda) fuels new label expansions, potentially rejuvenating market relevance in immunotherapy landscapes.

Pricing and Reimbursement Trends

• Pricing Strategies: Avastin’s premium pricing varies globally, with notable discounts in markets adopting biosimilars. Payer pressure influences reimbursement levels, especially in regionally constrained health systems.

• Cost-Effectiveness: Cost-effectiveness analyses indicate that, in several indications, Avastin's benefits justify its costs, although this is increasingly challenged by biosimilars and alternative therapies.

Market Projection and Future Outlook

Growth Drivers

• Expansion into New Indications: Continued clinical trials exploring Avastin in combination with immunotherapy and targeted agents are likely to underpin future indications, especially in ovarian, glioblastoma, and lung cancers.

• Biomarker-Driven Personalization: The integration of predictive biomarkers to identify responder populations could optimize efficacy, improve reimbursement prospects, and expand market share.

• Geographical Expansion: Increasing access in emerging markets like China, India, and Latin America, facilitated by biosimilars and price negotiations, will contribute to sustained growth.

Potential Challenges

• Safety Concerns and Regulatory Restrictions: Safety issues, including hemorrhage risk and hypertension, have led to restrictions in some indications, delaying or limiting market expansion.

• Erosion by Biosimilars: The growing availability of biosimilars is expected to dilute Avastin’s revenue, especially in mature markets.

• Competitive Therapeutics: The rise of newer immunotherapies and targeted agents may displace Avastin in certain indications, requiring strategic repositioning.

Forecast Summary

• Revenue Trajectory: Analysts project Avastin’s global revenues to stabilize at around USD 4-6 billion annually over the next five years, subject to indication-specific dynamics, biosimilar penetration, and regulatory developments.

• Innovation and R&D: Investment in combination trials and personalized medicine approaches is expected to sustain Avastin’s relevance. Roche’s development pipeline includes next-generation VEGF inhibitors and immune-modulating agents that may complement or replace Avastin in future regimens.

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Conclusion: Strategic Insights for Stakeholders

Avastin continues to hold a critical position in oncology therapeutics, supported by extensive clinical data, a broad label, and a strong market presence. However, the landscape is shifting towards biosimilars, personalized medicine, and combination immunotherapies. Stakeholders should monitor ongoing clinical trials closely, especially those investigating predictive biomarkers and novel combinations, to identify opportunities for extension and optimization. Market access strategies must adapt to regional regulatory and reimbursement trends, balancing innovation with cost-containment pressures.

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Key Takeaways

• Clinical Development: Recent trials focus on expanding Avastin’s indications, especially in combination with immunotherapies; personalized approaches remain pivotal.

• Market Position: Despite biosimilar competition, Avastin retains significant market dominance due to its extensive label and established efficacy profile.

• Competitive Pressure & Biosimilars: Biosimilars are gradually eroding Avastin’s revenue, prompting Roche to innovate through combination therapies and new indications.

• Regulatory and Safety Dynamics: Restrictions in certain indications have impacted growth; ongoing safety evaluations influence future approvals.

• Future Outlook: The integration of biomarker-driven strategies and combination regimens with immunotherapy promises to sustain Avastin’s relevance in the evolving oncology landscape.

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FAQs

1. What are the latest approved indications for Avastin?
   Avastin is currently approved for metastatic colorectal cancer, non-squamous NSCLC, glioblastoma, renal cell carcinoma, and certain gynecologic cancers. Recent label updates restrict some indications, especially in breast cancer.

2. How does biosimilar competition affect Avastin’s market?
   Biosimilars, such as SB8, offer comparable efficacy at reduced prices, leading to decreased Avastin sales in regions where biosimilar uptake is high, particularly in Europe and emerging markets.

3. Are there ongoing trials that might expand Avastin’s use?
   Yes, current trials are exploring Avastin combined with immunotherapies in lung, ovarian, and other cancers, which could broaden its therapeutic scope if successful.

4. What are the primary safety concerns associated with Avastin?
   Risks include hemorrhage, hypertension, proteinuria, and wound healing complications. These safety concerns influence regulatory decisions and patient selection.

5. What is the future outlook for Avastin’s revenue?
   While revenues are expected to stabilize at lower levels due to biosimilar competition, strategic innovation and new indication approvals could partially offset declines over the next five years.

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References

[1] MarketWatch. "Global Anti-VEGF Oncology Market Size & Share Analysis." 2022.
[2] FDA and EMA approval databases for biosimilars.