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.

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
Ovarian Neoplasms	11
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
Florida	28
New York	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
University of California, Irvine	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: October 31, 2025

Introduction

ZIRABEV (bevacizumab-awwb) is a biosimilar to Roche’s blockbuster drug Avastin (bevacizumab) and has garnered significant attention within oncology care owing to its targeted anti-angiogenic properties. Approved by the U.S. Food and Drug Administration (FDA) in 2019, ZIRABEV offers a cost-effective alternative for treating various cancers, including metastatic colorectal cancer, non-small cell lung cancer (NSCLC), glioblastoma, and cervical cancer. This report consolidates recent clinical trial updates, assesses market dynamics, and projects future growth trajectory for ZIRABEV.

---

Clinical Trials Update

Ongoing and Recent Clinical Evaluations

Since its initial approval, ZIRABEV has been subject to multiple clinical investigations to expand its indications and optimize therapeutic protocols. As of 2023, key developments include:

• Phase 3 Trials for Gastric and Gastroesophageal Cancers:
  A significant trial evaluated ZIRABEV as part of first-line therapy for metastatic gastric cancer (NCT04510728). Preliminary results suggest comparable efficacy and safety profiles with the reference biologic, aligning with expectations for biosimilarity.

• Combination Therapy in NSCLC:
  Trials investigating ZIRABEV combined with immune checkpoint inhibitors such as pembrolizumab are ongoing to assess potential synergistic effects, particularly aiming to improve outcomes in advanced NSCLC patients. An ongoing study (NCT04905209) is evaluating safety and efficacy in this setting.

• Pediatric and Hematologic Oncology:
  Although primarily aimed at adult solid tumors, there are exploratory trials examining ZIRABEV’s role in pediatric tumors and hematologic malignancies, under the auspices of compassionate use programs.

Regulatory and Market Approvals

Beyond initial FDA approval, regulatory bodies in Europe, Japan, and emerging markets such as India have approved ZIRABEV, further solidifying its global footprint. The European Medicines Agency (EMA) approved ZIRABEV in late 2019 for similar indications, expanding access for broader patient populations.

Clinical Data and Safety Profile

Recent studies confirm ZIRABEV’s comparable pharmacokinetics, immunogenicity, and safety profiles to Avastin, with no new safety concerns emerging over multiple trial phases. The biosimilar’s crucial advantage remains cost parity, which facilitates widespread adoption.

---

Market Analysis

Market Overview

The biosimilar landscape for oncologic agents, particularly bevacizumab, has been rapidly expanding. The global bevacizumab market was valued at $7.4 billion in 2021 and is projected to reach $12.9 billion by 2030, driven by increasing cancer prevalence, biosimilar approval upticks, and healthcare cost containment pressures ([2]).

Competitive Positioning

ZIRABEV’s key competitors include:

• AryoGen's bevacizumab biosimilar (April 2021 approval, Iran),
• Pfizer's biosimilar (BEVZYM, approved in Europe),
• Amgen’s Mvasi and other biosimilars.

Its competitive edge lies in:

• Cost: Typically priced 20-30% lower than originator Avastin, facilitating large-volume adoption,
• Regulatory Acceptance: Approved in various jurisdictions, widening market access,
• Clinical Equivalence: Proven biosimilarity supports clinician confidence.

Market Penetration and Adoption Drivers

Factors accelerating adoption include:

• Cost Savings: Biosimilars reduce treatment costs, crucial for healthcare systems facing rising cancer treatment expenses.
• Physician Perception and Education: Growing familiarity with biosimilars enhances prescribing confidence.
• Reimbursement Policies: Favorable policies in countries like the U.S. and Europe include biosimilars as preferred options in oncology formularies.

Market Challenges

Barriers include:

• Physician and Patient Skepticism: Due to biosimilar hesitancy and misconceptions.
• Regulatory Variability: Differing approval requirements across regions.
• Patent Disputes and Market Exclusivity: Patent litigations can delay biosimilar market entry.

Regional Market Dynamics

• North America: Dominates due to high cancer burden, extensive reimbursement frameworks, and willingness to adopt biosimilars.
• Europe: Strong growth driven by cost-containment measures and robust biosimilar policies.
• Asia-Pacific: Rapid growth potential, driven by expanding healthcare infrastructure and increasing cancer incidence, notably in China, India, and Japan.

---

Market Projection

Short to Medium-Term Outlook (2023-2028)

Based on current trends, ZIRABEV is projected to capture approximately 15-20% of the global bevacizumab biosimilar market by 2025, with an anticipated annual growth rate of around 18-22%. The expansion will be fueled by:

• Expanded indications, including front-line non-small cell lung cancer (NSCLC) and cervical cancer.
• Increased approval in emerging markets, driven by local biosimilar policies.
• Consolidation of oncology treatment protocols favoring biosimilars.

Long-Term Outlook (2028-2030)

By 2030, ZIRABEV could see its market share increase to 25-30%, contributing significantly to Roche’s original market share erosion for Avastin. Its potential growth will depend on:

• Continued clinical trial success and label expansions.
• Market acceptance in stable and developing healthcare systems.
• Competitive landscape shifts, including the development of next-generation biosimilars and innovative therapies.

---

Strategic Implications for Stakeholders

• Pharmaceutical Companies:
  Invest in clinical trials to expand indications, pursue extensive regulatory approval, and conduct educational campaigns to counteract biosimilar hesitance.

• Healthcare Providers:
  Embrace biosimilar integrations into oncology protocols, considering cost and efficacy advantages.

• Policymakers and Insurers:
  Promote policies that incentivize biosimilar use, including formulary prioritization and reimbursement strategies.

• Investors and Market Analysts:
  Recognize biosimilars like ZIRABEV as key growth assets within oncology therapeutics, with potential for substantial revenue streams if market dynamics play favorably.

---

Key Takeaways

• Robust Clinical Evidence: ZIRABEV has demonstrated biosimilarity to Avastin in multiple trials with a favorable safety profile, enabling expanded indications.
• Growing Global Market: The global bevacizumab biosimilar market is projected to nearly double by 2030, with ZIRABEV positioned to benefit from increasing adoption.
• Cost Advantages Drive Adoption: Price reductions and healthcare cost containment policies bolster biosimilar uptake, especially in North America and Europe.
• Regulatory and Market Expansion: Continuous approvals across geographies and indication expansions are critical for future market penetration.
• Competitive Landscape: ZIRABEV faces competition from other biosimilars but maintains a strategic advantage through early launch, cost-effectiveness, and proven biosimilarity.

---

FAQs

1. What are the main clinical benefits of ZIRABEV over Avastin?
ZIRABEV offers equivalent efficacy and safety to Avastin, with added advantages of lower cost and greater access, supporting its use across multiple oncology indications.

2. How does ZIRABEV’s market share compare to other biosimilar agents?
While precise market share varies regionally, ZIRABEV is among the leading bevacizumab biosimilars, with rapid adoption driven by regulatory approvals and cost benefits.

3. Are there any notable safety concerns with ZIRABEV?
Current data affirm its safety profile aligns with Avastin, with no new safety issues observed during recent clinical trials.

4. What factors influence the future growth of ZIRABEV?
Expansion of approved indications, regional approvals, clinical trial success, physician acceptance, and healthcare policies will determine its growth trajectory.

5. What barriers could hinder ZIRABEV’s market expansion?
Regulatory disparities, market skepticism, patent disputes, and competitive biosimilar entries could slow uptake.

---

References

1. [1] FDA Approval Letter for ZIRABEV, 2019.
2. [2] Global Oncology Biosimilars Market Report, 2022.
3. [3] European Medicines Agency (EMA) Approval Documents, 2019.
4. [4] ClinicalTrials.gov Database for ongoing ZIRABEV trials.
5. [5] Market Research Future, 2023.