CLINICAL TRIALS PROFILE FOR BEVACIZUMAB

Biosimilar Clinical Trials for bevacizumab

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).
NCT02879097 ↗	Efficacy-Safety-Immunogenicity Study of CBT124&EU-sourced Avastin® in Stage 4 NSCLC	Unknown status	Cipla BioTec Pvt. Ltd.	Phase 3	2016-12-01	The purpose of this study is to determine whether CBT124 and Avastin® are comparable in terms of efficacy, safety, immunogenicity; and whether the pharmacokinetics of CBT124 matches that of Avastin® (pharmacokinetics is nested in this study for Indian patients).

All Clinical Trials for bevacizumab

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00006786 ↗	Combination Chemotherapy Plus Bevacizumab in Treating Patients With Advanced Colorectal Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2000-11-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bevacizumab may stop the growth of colorectal cancer by stopping blood flow to the tumor. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus bevacizumab in treating patients who have advanced colorectal cancer.
NCT00006786 ↗	Combination Chemotherapy Plus Bevacizumab in Treating Patients With Advanced Colorectal Cancer	Completed	Eastern Cooperative Oncology Group	Phase 2	2000-11-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bevacizumab may stop the growth of colorectal cancer by stopping blood flow to the tumor. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus bevacizumab in treating patients who have advanced colorectal cancer.
NCT00015951 ↗	Bevacizumab, Cytarabine, and Mitoxantrone on Treating Patients With Hematologic Cancers	Completed	National Cancer Institute (NCI)	Phase 2	2001-04-01	RATIONALE: Monoclonal antibodies such as bevacizumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may be an effective treatment for hematologic cancer. PURPOSE: Phase II trial to study the effectiveness of bevacizumab combined with cytarabine and mitoxantrone in treating patients who have hematologic cancer.
NCT00015951 ↗	Bevacizumab, Cytarabine, and Mitoxantrone on Treating Patients With Hematologic Cancers	Completed	University of Maryland Greenebaum Cancer Center	Phase 2	2001-04-01	RATIONALE: Monoclonal antibodies such as bevacizumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may be an effective treatment for hematologic cancer. PURPOSE: Phase II trial to study the effectiveness of bevacizumab combined with cytarabine and mitoxantrone in treating patients who have hematologic cancer.
NCT00015951 ↗	Bevacizumab, Cytarabine, and Mitoxantrone on Treating Patients With Hematologic Cancers	Completed	University of Maryland	Phase 2	2001-04-01	RATIONALE: Monoclonal antibodies such as bevacizumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may be an effective treatment for hematologic cancer. PURPOSE: Phase II trial to study the effectiveness of bevacizumab combined with cytarabine and mitoxantrone in treating patients who have hematologic cancer.
NCT00015951 ↗	Bevacizumab, Cytarabine, and Mitoxantrone on Treating Patients With Hematologic Cancers	Completed	University of Maryland, Baltimore	Phase 2	2001-04-01	RATIONALE: Monoclonal antibodies such as bevacizumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may be an effective treatment for hematologic cancer. PURPOSE: Phase II trial to study the effectiveness of bevacizumab combined with cytarabine and mitoxantrone in treating patients who have hematologic cancer.
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.

Clinical Trial Conditions for bevacizumab

Condition Name

Condition Name for bevacizumab
Intervention	Trials
Colorectal Cancer	246
Metastatic Colorectal Cancer	146
Breast Cancer	137
Ovarian Cancer	119

Condition MeSH

Condition MeSH for bevacizumab
Intervention	Trials
Colorectal Neoplasms	582
Carcinoma, Non-Small-Cell Lung	289
Carcinoma	277
Lung Neoplasms	266

Clinical Trial Locations for bevacizumab

Trials by Country

Trials by Country for bevacizumab
Location	Trials
United States	7,782
China	670
Italy	634
Spain	512
Japan	396

Trials by US State

Trials by US State for bevacizumab
Location	Trials
California	418
Texas	370
New York	325
Florida	305
Ohio	302

Clinical Trial Progress for bevacizumab

Clinical Trial Phase

Clinical Trial Phase for bevacizumab
Clinical Trial Phase	Trials
PHASE4	13
PHASE3	44
PHASE2	230

Clinical Trial Status

Clinical Trial Status for bevacizumab
Clinical Trial Phase	Trials
Completed	1145
RECRUITING	576
Terminated	234

Clinical Trial Sponsors for bevacizumab

Sponsor Name

Sponsor Name for bevacizumab
Sponsor	Trials
Genentech, Inc.	335
National Cancer Institute (NCI)	324
Hoffmann-La Roche	193

Sponsor Type

Sponsor Type for bevacizumab
Sponsor	Trials
Other	2974
Industry	1560
NIH	342

Bevacizumab Clinical Trials Update, Market Analysis, and 2026–2035 Revenue Projection

Last updated: July 22, 2026

Bevacizumab (Avastin; Genentech/Roche) remains the leading oncology anti-VEGF antibody franchise globally, with continued uptake in colorectal, lung, renal cell, cervical, and glioblastoma care settings. Growth is now driven less by first-line label expansion and more by geographic scaling, regimen repositioning with combination standards, and life-cycle gains from formulation and dose-optimization strategies. Patent and exclusivity timelines continue to shape biosimilar and oncology procurement dynamics, with competition concentrated in the US and EU where procurement scale and payer policy determine net pricing.

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How is bevacizumab’s clinical trial pipeline evolving in 2024–2026?

As of the 2024–2026 period, bevacizumab trial activity remains heavy in solid tumors and biomarker-selected combinations, with recurrent themes:

• Switching from bevacizumab monotherapy to higher-evidence combinations (chemotherapy backbones, immuno-oncology partners, and targeted agents).
• Refining patient selection via predictive biomarkers (VEGF pathway signals, angiogenesis signatures, and radiographic endpoints).
• Investigating sequencing and duration strategies to reduce exposure while maintaining progression control.
• Trial programs in rare solid tumor populations and CNS settings (including recurrent glioblastoma), though conversion from phase 2 to phase 3 has historically been slower in CNS.

Which bevacizumab clinical trial areas show the most continued enrollment?

• Metastatic colorectal cancer (mCRC): trials exploring optimal pairing with chemotherapy regimens and targeted therapies; emphasis on resistance modulation and maintenance strategies.
• Non-small cell lung cancer (NSCLC): bevacizumab remains embedded in systemic standards; trials typically focus on combinations and duration.
• Renal cell carcinoma (RCC): bevacizumab in combination with checkpoint inhibitors or TKIs is studied across lines and in regional practice variants.
• Ovarian and endometrial cancers: trials focus on biomarker stratification, maintenance, and relapse combinations.
• Cervical cancer: trials aim to preserve survival benefit with reduced toxicity and improved delivery strategies.
• Glioblastoma: trials continue, but regulatory translation is difficult given endpoints and heterogeneous disease biology.

What are the most common endpoints being used?

• PFS as the primary endpoint in many solid tumor programs.
• OS as key secondary endpoint where survival signals are expected and follow-up is feasible.
• ORR and DoR in earlier-line or exploratory combination arms.
• Safety and tolerability with specific emphasis on class risks (hypertension, proteinuria, bleeding, thromboembolism, GI perforation, wound healing complications).

What is the practical impact on near-term launch and payer adoption?

Pipeline updates most directly influence near-term purchasing through:

• New or expanded guideline positioning in specific geographies.
• Dose scheduling and regimen standardization that reduces out-of-pocket and infusion burden.
• Evidence supporting biomarker-guided use that can shift payer coverage toward defined subpopulations.

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What is the global bevacizumab market size and growth outlook?

Bevacizumab is one of the largest oncology biologics by global revenue history. Market growth rates in recent years have been moderated by biosimilar entry in multiple markets, patent-driven pricing power erosion, and discounting tied to tender economics.

Market drivers

1. Broad label footprint across major solid tumors
2. Ongoing combination regimens in first-line and subsequent lines
3. Geographic substitution and hospital formulary uptake
4. Biosimilar competition lowering list prices but expanding access
5. Treatment intensity remains durable despite chemotherapy and IO competition

Market headwinds

• Net price compression due to biosimilar and tender-driven discounting.
• Regimen shifts when competitors demonstrate superior outcomes in specific subtypes.
• Safety management costs (hospital protocols for class adverse events).
• Oncology budget constraints as payer systems manage high-cost biologics.

2026–2035 revenue projection approach (market-level)

A robust projection for bevacizumab must model:

• Unit volume growth (incidence of treated patients, regimen persistence, and access expansion)
• Net price erosion from biosimilars and contracting
• Geographic mix shift to markets with later biosimilar penetration
• Share impacts from competing IO-TKI and IO-ADC standards

Projection headline (global):

• 2026–2030: moderate revenue growth in units offset by net price compression. Net revenue largely tracks volume growth with a declining price curve.
• 2031–2035: lower growth as biosimilar penetration matures, with volume growth increasingly limited by ceiling effects in mature markets and by competitive regimen substitution.

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How do bevacizumab biosimilars change pricing, access, and hospital tender outcomes?

Biosimilars are the dominant determinant of net price trajectory after initial reference product patent exclusivity windows and regulatory exclusivity periods end. Procurement frequently uses:

• Tender-based award to lowest net-cost supplier
• Hospital formulary tiering with automatic switch policies
• Pharmacy and therapeutic committee protocols tied to interchangeability and pharmacovigilance

Key biosimilar dynamics

• Multiple biosimilars in parallel intensify discounting and reduce reference share.
• Switching policies influence realized demand for biosimilars.
• Tender frequency and contracting create sudden net price steps down.
• Therapeutic equivalence supports uptake, while prescriber trust affects switching speed.

Why this matters for revenue projection

Even if total treated-patient numbers grow, revenue can stagnate when:

• Net price declines outpace volume gains
• Consolidation among biosimilar suppliers reduces effective price dispersion
• Payer preferencing favors biosimilar bundles that reduce margin for the incumbent

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What patents protect bevacizumab, and when do they expire?

Bevacizumab’s patent landscape is complex because it spans:

• Original molecule and engineering improvements
• Formulation and manufacturing method claims
• Additional indications and method-of-use claims (depending on jurisdiction)
• Process patents for cell lines, purification, and analytics

For business planning, the key point is that the reference product has long passed core molecule exclusivity and that current risk is tied to:

• Formulation/manufacturing improvements
• Specific method-of-use claims that can delay biosimilar uptake in narrow settings
• Litigation-driven injunctions where they exist

Patent estate implication for market access

• In broad oncology indications where no effective method-of-use barriers exist, biosimilars generally gain formulary access quickly after regulatory clearance.
• Where method-of-use or patient-subset claims are enforced, conversion can slow and create localized pricing stability.

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What is the FDA and EMA regulatory status of bevacizumab and its biosimilars?

Bevacizumab (Avastin) has a long-standing FDA approval history for multiple indications and is regulated as a monoclonal antibody biologic.

For biosimilars:

• FDA clearance typically relies on a totality-of-evidence biosimilarity package (structural/functional similarity, clinical PK/PD, immunogenicity, and comparative clinical data in at least one indication).
• EMA approval likewise uses biosimilarity and clinical comparability frameworks under European biosimilar regulation.

Practical regulatory impact

• Once a biosimilar clears, the commercial impact depends on:
  • interchange and substitution policies in each country
  • pricing and tender frameworks
  • prescriber and center switching practices

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Where does bevacizumab generate revenue by indication?

Bevacizumab revenue historically concentrates in:

• Metastatic colorectal cancer
• NSCLC
• RCC
• Cervical cancer
• Ovarian cancer
• Glioblastoma

Indication-by-indication commercial sensitivity

• mCRC and NSCLC: high volume, high regimen persistence, strong payer influence via contracting.
• RCC: combination standards can shift rapidly with new IO and TKI combinations; bevacizumab share depends on guideline updates and reimbursement positioning.
• Cervical cancer: stable demand where bevacizumab is entrenched in protocols.
• Glioblastoma: smaller market but continued trial activity due to unmet need.

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How does bevacizumab compare with competing anti-angiogenesis and IO regimens?

Competitive pressure often comes from:

• VEGF pathway competitors
• IO regimens that replace or reduce need for VEGF blockade in certain subtypes
• ADC and T-cell engagement therapies in later lines

Relative competitive standing

• Bevacizumab’s strength is its:
  • broad label and deep clinical experience across solid tumors
  • established combination infrastructure in community and academic oncology
  • biosimilar availability increasing access

What tends to erode share

• New survival or safety advantages that re-rank first-line standards in subsets
• Payer preferencing of newer regimens even when bevacizumab remains effective
• Safety management complexity increasing total cost-of-care compared with simpler regimens

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What generic and biosimilar entry risks exist for bevacizumab?

For a reference biologic, the relevant “generic” risk is biosimilar entry rather than small-molecule generics.

Risk categories

1. Regulatory: biosimilar approval success and launch timing
2. Legal: method-of-use and manufacturing/formulation IP that could limit adoption in practice
3. Commercial: tender award to biosimilars and prescriber switching speed
4. Operational: supply continuity, lead times, and pharmacovigilance readiness

Near-term commercial risk

The biggest risk to reference revenue is not regulatory clearance alone but realized pricing, which is determined by:

• national tender frameworks
• contracting power of large hospital networks
• biosimilar portfolio competition at scale

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What bevacizumab litigation affects market entry and pricing?

Biosimilar litigation historically affects:

• timing of injunctions or negotiated “at-risk” launches
• settlement agreements that can shift market shares and contract timing

At a high level, the litigation map typically clusters around:

• antibody-related claims
• formulation/manufacturing improvements
• indication and method-of-use claims

Business implication

If litigation delays are confined to narrow indications, the broader commercial picture remains driven by:

• regulatory launch dates
• tender schedules
• payer switching frameworks

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How strong is the patent estate for bevacizumab versus biosimilars?

A strong patent estate can delay biosimilar uptake even after regulatory approval. But for bevacizumab, the market is now long into biosimilar penetration, so:

• the remaining enforceable value is typically narrower and more litigated
• the practical effect is a patchwork of localized adoption speed rather than a wholesale block

Where patent strength tends to matter most

• If a method-of-use claim is tied to an adopted standard of care in a large subset of patients
• If a formulation or manufacturing claim impacts supply chain readiness or interchangeability policies
• If injunction scope covers a specific presentation and dosing protocol

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What are the most commercially relevant bevacizumab formulations and dosing strategies?

Bevacizumab is used as an IV monoclonal antibody with dosing regimens that vary by:

• indication and line of therapy
• combination partner regimen
• patient tolerance and risk profile

Life-cycle strategies

• Dose optimization and schedule refinements
• Pharmacovigilance programs to support center switching
• Sterility and supply stability focus as biosimilar competitors scale

These factors tend to influence:

• real-world persistence
• total administered dose per patient
• procurement confidence and inventory management

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Key Takeaways

• Bevacizumab’s clinical development focus through 2024–2026 centers on combination optimization, biomarker selection, and sequencing/duration refinement across major solid tumors.
• Market revenue growth is increasingly constrained by biosimilar-driven net price compression, with volume growth and geographic access gains doing most of the work in the 2026–2030 window.
• Patent and legal dynamics now affect localized adoption speed more than they determine whether biosimilars can launch broadly.
• Revenue projection from 2026–2035 should be modeled using a contracting-tender pricing curve plus volume persistence by indication, with special sensitivity in mCRC and NSCLC due to high volume and fast payer adoption of lower-net-cost products.

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FAQs

1. Which bevacizumab indications are most sensitive to biosimilar-driven net price erosion?
2. How do tender and hospital formulary policies determine bevacizumab biosimilar share in the US versus EU?
3. Do bevacizumab trials in glioblastoma materially change the commercial outlook?
4. What safety and pharmacovigilance considerations slow real-world biosimilar switching for bevacizumab?
5. How should a revenue model separate units growth from net pricing for bevacizumab through 2035?

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References

1. (Sources not provided in the prompt; no citations can be generated.)