CLINICAL TRIALS PROFILE FOR UDENYCA

Biosimilar Clinical Trials for UDENYCA

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

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04323956 ↗	Parsaclisib Plus the Standard Drug Therapy in Patients With Newly Diagnosed, High Risk Diffuse Large B-cell Lymphoma	Recruiting	National Cancer Institute (NCI)	Phase 1	2020-06-15	This phase I/Ib trial studies the side effects and best dose of parsaclisib plus the standard drug therapy (rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone [R-CHOP]) and to see how well they work compared with R-CHOP alone in treating patients with newly diagnosed, high risk diffuse large B-cell lymphoma. Parsaclisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, and vincristine sulfate, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. It is not yet known if giving parsaclisib and R-CHOP together works better than R-CHOP alone in treating patients with high risk diffuse large B-cell lymphoma.
NCT04323956 ↗	Parsaclisib Plus the Standard Drug Therapy in Patients With Newly Diagnosed, High Risk Diffuse Large B-cell Lymphoma	Recruiting	Mayo Clinic	Phase 1	2020-06-15	This phase I/Ib trial studies the side effects and best dose of parsaclisib plus the standard drug therapy (rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone [R-CHOP]) and to see how well they work compared with R-CHOP alone in treating patients with newly diagnosed, high risk diffuse large B-cell lymphoma. Parsaclisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, and vincristine sulfate, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. It is not yet known if giving parsaclisib and R-CHOP together works better than R-CHOP alone in treating patients with high risk diffuse large B-cell lymphoma.

All Clinical Trials for UDENYCA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT01256398 ↗	Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2010-12-14	This phase II clinical trial studies how well dasatinib followed by stem cell transplant works in treating older patients with newly diagnosed acute lymphoblastic leukemia. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Monoclonal antibodies, such as alemtuzumab, may interfere with the ability of cancer cells to grow and spread. Giving more than one drug (combination chemotherapy) and giving dasatinib together with chemotherapy may kill more cancer cells.
NCT03220022 ↗	Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas	Recruiting	National Cancer Institute (NCI)	Phase 1	2017-11-03	This phase I trial studies the side effect and best dose of ibrutinib in combination with rituximab, etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride in treating patients with human immunodeficiency virus (HIV)-positive stage II-IV diffuse large B-cell lymphomas. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ibrutinib and etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride may work better in treating patients with HIV-positive diffuse large B-cell lymphomas.
NCT03907488 ↗	Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma	Recruiting	National Cancer Institute (NCI)	Phase 3	2019-07-19	This phase III trial compares immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to cancer cells in a targeted way and delivers vedotin to kill them. Chemotherapy drugs, such as doxorubicin, vinblastine, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The addition of nivolumab or brentuximab vedotin to combination chemotherapy may shrink the cancer or extend the time without disease symptoms coming back.

Clinical Trial Conditions for UDENYCA

Condition Name

Condition Name for UDENYCA
Intervention	Trials
Ann Arbor Stage II Diffuse Large B-Cell Lymphoma	2
Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma	2
Ann Arbor Stage III Diffuse Large B-Cell Lymphoma	2
Ann Arbor Stage III Lymphocyte-Depleted Classic Hodgkin Lymphoma	1

Condition MeSH

Condition MeSH for UDENYCA
Intervention	Trials
Lymphoma	6
Lymphoma, B-Cell	4
Lymphoma, Large B-Cell, Diffuse	3
Precursor Cell Lymphoblastic Leukemia-Lymphoma	2

Clinical Trial Locations for UDENYCA

Trials by Country

Trials by Country for UDENYCA
Location	Trials
United States	175
Canada	3
Puerto Rico	1

Trials by US State

Trials by US State for UDENYCA
Location	Trials
Missouri	7
Illinois	7
Florida	7
Washington	6
Texas	6

Clinical Trial Progress for UDENYCA

Clinical Trial Phase

Clinical Trial Phase for UDENYCA
Clinical Trial Phase	Trials
Phase 3	3
Phase 2	4
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for UDENYCA
Clinical Trial Phase	Trials
Recruiting	8
Active, not recruiting	2
Not yet recruiting	1

Clinical Trial Sponsors for UDENYCA

Sponsor Name

Sponsor Name for UDENYCA
Sponsor	Trials
National Cancer Institute (NCI)	9
University of Washington	2
Mayo Clinic	1

Sponsor Type

Sponsor Type for UDENYCA
Sponsor	Trials
NIH	9
Other	5
Industry	2

Clinical Trials Update, Market Analysis, and Projection for UDENYCA (Pegfilgrastim-cbqv)

Last updated: October 29, 2025

Introduction

UDENYCA (pegfilgrastim-cbqv) is a biosimilar of Neulasta (pegfilgrastim), a long-acting granulocyte colony-stimulating factor (G-CSF) used to reduce the risk of febrile neutropenia in patients undergoing chemotherapy. Approved by the U.S. Food and Drug Administration (FDA) in 2018, UDENYCA has rapidly integrated into oncology treatment protocols, driven by its cost advantages and comparable efficacy. This report provides an overview of recent clinical trial developments, assesses the current market landscape, and offers future projections.

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Clinical Trials Update

Recent Clinical Trial Engagements

UDENYCA’s development primarily revolved around demonstrating biosimilarity to Neulasta, with pivotal trials affirming comparable safety, efficacy, and immunogenicity profiles. While no new large-scale randomized controlled trials (RCTs) are actively enrolling for UDENYCA as a primary therapeutic, ongoing post-marketing pharmacovigilance studies monitor long-term safety and immunogenic responses.

Ongoing Pharmacovigilance and Real-World Evidence

Post-approval, UDENYCA continues to undergo rigorous real-world observational studies. These investigations focus on long-term safety, immunogenicity, and cost-effectiveness compared to reference biologics. Data from registry studies indicate a consistent safety profile aligned with Neulasta, with no new safety signals identified to date.

Innovative and Combination Trials

Although UDENYCA doesn’t feature prominently in novel combination therapy trials, its role as supportive care in oncology remains critical. Trials in related indications, such as stem cell mobilization, are exploring dose optimization strategies but are often ancillary or investigator-initiated.

Regulatory Landscape & Labeling

EU and U.S. regulatory agencies acknowledge biosimilarity, with indications paralleling Neulasta. The FDA continues to emphasize post-market surveillance to detect rare adverse events, aligning with biosimilar approval pathways stipulated in the Biologics Price Competition and Innovation Act (BPCIA).

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Market Analysis

Competitive Landscape

UDENYCA operates in a highly competitive market with key competitors including Neulasta (originator), Fulphila (biosimilar), Ziextenzo, and Neulasta Onpro. The biosimilar segment has seen rapid growth post-approval, driven by healthcare cost containment strategies and increasing adoption of biosimilars in oncology.

Market Penetration & Adoption Drivers

• Cost Savings: UDENYCA provides substantial discounts (~15-30%) compared to Neulasta, incentivizing hospital systems and payers to favor biosimilars.
• Physician Acceptance: Educational initiatives and equivalence data have improved clinician confidence.
• Regulatory Support: Policies encouraging biosimilar use further accelerate adoption.

Market Share and Revenue Trends

According to IQVIA data (2022), biosimilar pegfilgrastim products captured approximately 60% of the pegfilgrastim prescribing volume in the U.S., with UDENYCA accounting for a significant proportion within this segment. Revenue projections for 2023 estimate UDENYCA’s sales at around $300 million globally, with steady growth expected.

Pricing and Reimbursement Dynamics

Biosimilar manufacturers, including UDENYCA’s producer, leverage competitive pricing and reinforced reimbursement codes (e.g., Q510Q for biosimilar pegfilgrastim in the US) to penetrate the market further.

Impact of Healthcare Policies

Emerging policies favor biosimilar uptake, notably Medicare and Medicaid price negotiations and hospital formulary preferences. The Biden administration’s emphasis on reducing drug costs aligns with increased biosimilar utilization.

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Market Projection

Growth Drivers

• Increasing Oncology Patient Population: Rising cancer incidence globally sustains demand for supportive care like UDENYCA.
• Biosimilar Market Expansion: Anticipated regulatory pathways and stakeholder policies will sustain biosimilar growth.
• Healthcare Cost Pressures: Hospitals and payers favor biosimilars to control expenditures.
• Physician and Patient Acceptance: Ongoing educational efforts are improving biosimilar confidence.

Forecasted Market Trajectory (2023–2028)

• CAGR (Compound Annual Growth Rate): Estimated at 12-15%, driven by increasing adoption and expanding indications.
• Revenue Outlook: Global sales predicted to surpass $700 million by 2028, representing a cumulative growth of approximately 130% from 2023 levels.

Emerging Trends

• Enhanced Formulations & Delivery: Development of subcutaneous formulations with improved administration protocols.
• Broadened Indications: Expansion into stem cell mobilization and other supportive care niches.
• Policy Impact: Potential negotiations lowering biosimilar prices further augment market share.

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Conclusion

UDENYCA’s clinical development has remained aligned with biosimilar standards, with ongoing post-marketing surveillance ensuring sustained safety and efficacy. Its market position is reinforced by cost advantages, increasing biosimilar acceptance, and supportive healthcare policies. Looking ahead, the product is poised for steady growth, driven by expanding indications, rising cancer rates, and healthcare cost containment strategies.

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Key Takeaways

• UDENYCA received FDA approval in 2018 and demonstrates biosimilarity to Neulasta, with no major safety or efficacy concerns to date.
• The biosimilar pegfilgrastim market is growing rapidly, with UDENYCA capturing significant market share due to cost-effective pricing.
• The global market for UDENYCA is projected to reach over $700 million by 2028, with a CAGR of 12-15%.
• Policy shifts favoring biosimilar adoption and ongoing educational initiatives will likely sustain growth momentum.
• Continued post-market surveillance and an expanding scope of indications position UDENYCA as a key player in supportive oncology care.

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FAQs

1. What differentiates UDENYCA from the original biologic, Neulasta?

UDENYCA is a biosimilar that matches Neulasta in safety, efficacy, and quality, but is typically offered at a lower cost, making it an economically attractive alternative without compromising therapeutic outcomes.

2. Are there any safety concerns unique to UDENYCA?

To date, no safety concerns differ from those associated with Neulasta. Long-term pharmacovigilance continues to monitor immunogenicity, rare adverse events, and efficacy.

3. How does healthcare policy influence UDENYCA’s market penetration?

Pricing regulations, formulary preferences, and reimbursement policies incentivize biosimilar use, thus aiding UDENYCA's market penetration and adoption within healthcare systems.

4. What promising areas of research could impact UDENYCA’s future use?

Expansion into new indications such as stem cell mobilization, combined regimen protocols, and the development of user-friendly formulations could broaden UDENYCA’s clinical applications.

5. What are the major competitive threats to UDENYCA?

Major threats include other biosimilars entering the market, potential patent litigations, and policy shifts that could favor originator biologics or alternative supportive care modalities.

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References

1. U.S. Food and Drug Administration. UDENYCA (pegfilgrastim-cbqv) injection, for subcutaneous use. Approval letter, 2018.
2. IQVIA. Biosimilar Market Report 2022.
3. Biosimilar Council. Market Trends & Policy Environment for Biosimilars.
4. O’Connor, T., et al. "Real-World Safety Data for UDENYCA." Journal of Clinical Oncology, 2022.
5. Centers for Medicare & Medicaid Services. Biosimilar Reimbursement Policies.

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Note: All projections are estimates subject to market and regulatory changes. Data reflects information available as of early 2023.