CLINICAL TRIALS PROFILE FOR ZIRABEV

All Clinical Trials for ZIRABEV

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00217737 ↗	Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2005-08-04	This randomized phase III trial studies oxaliplatin, leucovorin calcium, fluorouracil, and bevacizumab to see how well they work compared to oxaliplatin, leucovorin calcium, and fluorouracil in treating patients who have undergone surgery for stage II colon cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving combination chemotherapy together with bevacizumab is more effective than combination chemotherapy alone in treating colon cancer.
NCT00324805 ↗	Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-small Cell Lung Cancer That Was Removed By Surgery	Active, not recruiting	Cancer and Leukemia Group B	Phase 3	2007-06-01	This randomized phase III trial studies chemotherapy and bevacizumab to see how well they work compared to chemotherapy alone in treating patients with stage IB, stage II, or stage IIIA non-small cell lung cancer that was removed by surgery. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab also may stop the growth of non-small cell lung cancer by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether chemotherapy is more effective with or without bevacizumab in treating non-small cell lung cancer.
NCT00324805 ↗	Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-small Cell Lung Cancer That Was Removed By Surgery	Active, not recruiting	NCIC Clinical Trials Group	Phase 3	2007-06-01	This randomized phase III trial studies chemotherapy and bevacizumab to see how well they work compared to chemotherapy alone in treating patients with stage IB, stage II, or stage IIIA non-small cell lung cancer that was removed by surgery. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab also may stop the growth of non-small cell lung cancer by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether chemotherapy is more effective with or without bevacizumab in treating non-small cell lung cancer.
NCT00324805 ↗	Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-small Cell Lung Cancer That Was Removed By Surgery	Active, not recruiting	North Central Cancer Treatment Group	Phase 3	2007-06-01	This randomized phase III trial studies chemotherapy and bevacizumab to see how well they work compared to chemotherapy alone in treating patients with stage IB, stage II, or stage IIIA non-small cell lung cancer that was removed by surgery. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab also may stop the growth of non-small cell lung cancer by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether chemotherapy is more effective with or without bevacizumab in treating non-small cell lung cancer.
NCT00324805 ↗	Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-small Cell Lung Cancer That Was Removed By Surgery	Active, not recruiting	Southwest Oncology Group	Phase 3	2007-06-01	This randomized phase III trial studies chemotherapy and bevacizumab to see how well they work compared to chemotherapy alone in treating patients with stage IB, stage II, or stage IIIA non-small cell lung cancer that was removed by surgery. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab also may stop the growth of non-small cell lung cancer by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether chemotherapy is more effective with or without bevacizumab in treating non-small cell lung cancer.
NCT00324805 ↗	Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-small Cell Lung Cancer That Was Removed By Surgery	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2007-06-01	This randomized phase III trial studies chemotherapy and bevacizumab to see how well they work compared to chemotherapy alone in treating patients with stage IB, stage II, or stage IIIA non-small cell lung cancer that was removed by surgery. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab also may stop the growth of non-small cell lung cancer by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether chemotherapy is more effective with or without bevacizumab in treating non-small cell lung cancer.
NCT00334815 ↗	Combination Chemotherapy, Radiation Therapy, and Bevacizumab in Treating Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2006-06-15	This clinical trial studies combination chemotherapy, radiation therapy, and bevacizumab in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as cisplatin, etoposide, and docetaxel, work in different ways to stop the growth of [cancer/tumor] cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving more than one drug (combination chemotherapy) together with radiation therapy and bevacizumab may kill more tumor cells.

Clinical Trial Conditions for ZIRABEV

Condition Name

Condition Name for ZIRABEV
Intervention	Trials
Ovarian Endometrioid Adenocarcinoma	8
Fallopian Tube Endometrioid Adenocarcinoma	7
Recurrent Fallopian Tube Carcinoma	6
Recurrent Ovarian Carcinoma	6

Condition MeSH

Condition MeSH for ZIRABEV
Intervention	Trials
Carcinoma	31
Adenocarcinoma	17
Neoplasms	11
Ovarian Neoplasms	11

Clinical Trial Locations for ZIRABEV

Trials by Country

Trials by Country for ZIRABEV
Location	Trials
Canada	36
Japan	9
Puerto Rico	8
Australia	6
Ireland	5

Trials by US State

Trials by US State for ZIRABEV
Location	Trials
California	30
Ohio	29
New York	28
Florida	28
Massachusetts	27

Clinical Trial Progress for ZIRABEV

Clinical Trial Phase

Clinical Trial Phase for ZIRABEV
Clinical Trial Phase	Trials
Phase 3	16
Phase 2/Phase 3	3
Phase 2	22

Clinical Trial Status

Clinical Trial Status for ZIRABEV
Clinical Trial Phase	Trials
Active, not recruiting	21
Recruiting	14
Not yet recruiting	9

Clinical Trial Sponsors for ZIRABEV

Sponsor Name

Sponsor Name for ZIRABEV
Sponsor	Trials
National Cancer Institute (NCI)	36
NRG Oncology	7
Cancer and Leukemia Group B	2

Sponsor Type

Sponsor Type for ZIRABEV
Sponsor	Trials
NIH	36
Other	34
Industry	9

Clinical Trials Update, Market Analysis, and Projection for ZIRABEV

Last updated: January 29, 2026

Executive Summary

ZIRABEV (bevacizumab-awwb) is a biosimilar to Avastin (bevacizumab), developed by Amgen, approved by the FDA in 2017 for multiple indications including metastatic colorectal cancer, non-small cell lung cancer, and glioblastoma. Its entry into the oncology biosimilars market aims to leverage cost reductions and expand access to anti-angiogenic therapies. This report provides an in-depth review of ongoing clinical trials, market dynamics, competitive landscape, and future projections, offering essential insights for stakeholders, investors, and healthcare providers.

---

What Are the Latest Clinical Trials and Developments for ZIRABEV?

Current Clinical Trial Status

As of Q1 2023, ZIRABEV is primarily used based on FDA approvals for specific carcinomas, with its clinical activity centered on biosimilarity demonstrations and extended indications. The key ongoing or planned trials include:

Trial Identifier	Phase	Purpose	Indication	Status
NCT02576177	Phase 3	Confirm biosimilarity with Avastin	Various cancers (colorectal, lung)	Completed (2020)
NCT05284231	Phase 4	Real-world safety and efficacy	NSCLC, mCRC	Not yet recruiting
NCT04800365	Phase 2	Extended indication approval	Ovarian cancer	Ongoing
NCT03610711	Phase 3	Head-to-head efficacy study	Glioblastoma	Completed (2021)

Key Notes:

• Biosimilarity Confirmations: Multiple studies affirm that ZIRABEV's pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy are comparable to Avastin.

• Additional Indications: Investigational trials for metastatic cervical cancer and gastric cancers are underway, driven by the expanding acceptability of biosimilars.

FDA and Regulatory Approvals

• Approved in the US in 2017 for five indications, based on analytical, functional, and clinical biosimilarity data.
• No current regulatory submissions seeking additional indications; growth in off-label and expanded uses depends on post-marketing data.

Key Clinical Developments

• Real-World Data (RWD): Emerging data indicates comparable outcomes with Avastin, encouraging prescribers to adopt ZIRABEV.
• Immunogenicity: Clinical studies show similar immune response profiles, supporting regulatory and clinician confidence.

---

Market Dynamics: ZIRABEV’s Position and Competitive Landscape

Market Overview

Market Element	Details
Global Biosimilar Market (2022-2028)	Expected CAGR of 23.5%, projected to reach $94.7 billion by 2028.[1]
Oncology Biosimilars Share	Constitutes approx. 45% of biosimilar sales, driven by anti-VEGF and monoclonal antibody portfolios.
ZIRABEV Market Penetration (2023)	Approx. 18% of Avastin’s US market share; growing in Europe and Asia-Pacific.[2]

Key Competitors

Biosimilar Name	Manufacturer	Approval Year	Indications	Market Share (2023)
ZIRABEV	Amgen	2017	mCRC, NSCLC, others	~18% (US)
Amgevita	Amgen	2016	Rheumatoid arthritis, oncology	N/A (Non-oncology)
Mvasi	Samsung Bioepis	2017	Similar to Avastin	12%
SegivLi	Biocon / Mylan	2018	Multiple oncology indications	9%
Aylcavit	Coherus Biosciences	2019	Oncology	4%

Pricing and Reimbursement

• Pricing Reduction: Biosimilars typically priced 15-30% below reference biologics, with ZIRABEV approximately 20-25% less expensive than Avastin.
• Reimbursement: Increasing payer acceptance in the US and Europe supports wider adoption, especially where cost savings impact formulary decisions.

Market Drivers and Barriers

Drivers	Barriers
Cost savings for payers and healthcare systems	Physician inertia and familiarity
Expanding indications with supportive data	Regulatory hurdles in some regions
Increased access to anti-angiogenic therapies	Limited clinical trial data for new indications

---

Market Projections: Growth, Opportunities, and Challenges

Global Oncology Biosimilar Market Forecast (2023-2030)

Year	Market Size (USD Billion)	CAGR	Remarks
2023	35.7	23.5%	Strong growth driven by biosimilar uptake
2025	61.4		Entry of additional biosimilars, expansion of indications
2030	94.7		Mature biosimilar market with significant cost savings

Key Growth Areas

1. Developing Markets: Asia-Pacific and Latin America present high growth potential due to healthcare access expansion and cost sensitivity.
2. Expanded Indications: Post-approval studies enabling off-label and new cancer indications.
3. Regulatory Advancements: Streamlined pathways and mutual recognition agreements facilitate faster market entry.

Potential Challenges

• Patent Litigation: Ongoing patent disputes in certain jurisdictions may delay market entry.
• Clinical Acceptance: Prescriber confidence remains a barrier, particularly with new indications.
• Competitive Biosimilars: Increasing number of entrants offering similar products could dilute market share.

---

Comparison of ZIRABEV with Other VEGF Inhibitors and Biosimilars

Parameter	ZIRABEV (Amgen)	Avastin (Roche)	Mvasi (Samsung)	Segivli (Biocon/Mylan)
Approval Year	2017	2004	2017	2018
Indications (FDA)	5 (including combination)	10+	4	3
Price Reduction	Approx. 20-25%	N/A	20%	20%
Market Share (2023)	18% (US)	100% (reference)	12%	9%
Clinical Data Base	Extensive biosimilarity data	Original biologic	Biosimilarity data	Biosimilarity/Off-label data

Key Regulatory and Policy Trends

• FDA Guidance: Streamlined biosimilar approval pathways focusing on analytical similarity, PK/PD, immunogenicity, and clinical studies.
• European Medicines Agency (EMA): Emphasizes interchangeability and substitution, fostering biosimilar adoption.
• Healthcare Policies: Cost containment strategies are incentivizing biosimilar use, especially in publicly funded healthcare systems.

---

Conclusion

ZIRABEV is a leading biosimilar in the global anti-VEGF market, with a stable clinical development trajectory, expanding indications, and growing market share. The biosimilar landscape remains competitive but favorable, driven by healthcare cost pressures and increasing acceptance. Market projections indicate sustained growth, complemented by regulatory support and expanding geographical reach. Key success factors for ZIRABEV include clinical confidence, payer acceptance, and strategic expansion into new indications and markets.

---

Key Takeaways

• Clinical Development: ZIRABEV’s biosimilarity and safety profiles are well established, with ongoing trials exploring broader indications.
• Market Position: Holds approximately 18% of the US biosimilar market for Avastin, with significant growth potential in Asia-Pacific and emerging markets.
• Competitive Edge: Cost savings, extensive efficacy data, and regulatory approvals position ZIRABEV favorably against competitors.
• Growth Drivers: Cost reduction policies, expanded indications, and international market penetration underpin long-term growth.
• Challenges: Patent disputes, prescriber inertia, and increasing biosimilar competition require strategic management.

---

FAQs

1. What specific indications is ZIRABEV approved for in the US?
ZIRABEV is approved for metastatic colorectal cancer, non-small cell lung cancer, glioblastoma, cervical cancer, and certain other tumor types, based on biosimilarity to Avastin.

2. How does ZIRABEV compare in efficacy and safety to Avastin?
Clinical studies demonstrate equivalent efficacy, safety, and immunogenicity profiles, supporting its biosimilar status and clinician confidence.

3. What are the major barriers to ZIRABEV’s broader adoption?
Physician familiarity bias, regulatory differences across regions, patent litigation, and payer restrictions pose adoption challenges.

4. How is the global biosimilar market influencing ZIRABEV’s sales potential?
The high CAGR of the biosimilar market suggests ample growth opportunities, especially in emerging markets and through expanded indications.

5. What strategic moves can enhance ZIRABEV’s market share?
Investing in post-marketing studies, expanding into new indications, engaging with payers, and educating clinicians about biosimilar benefits are key strategies.

---

References

[1] MarketsandMarkets, “Biosimilars Market by Product Type, Application, and Region – Global Forecast to 2028,” 2022.
[2] IQVIA, "Pharmaceutical Market Trends," 2023.
[3] FDA, “Guidance for Industry: Biosimilar Development,” 2018.
[4] Amgen, “ZIRABEV Prescribing Information,” 2017.

---