CLINICAL TRIALS PROFILE FOR NEULASTA

Biosimilar Clinical Trials for NEULASTA

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

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01516736 ↗	Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim	Completed	Sandoz GmbH	Phase 3	2012-03-01	The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.
NCT01516736 ↗	Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim	Completed	Sandoz	Phase 3	2012-03-01	The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.
NCT01624805 ↗	Methylprednisolone, Horse Anti-Thymocyte Globulin, Cyclosporine, Filgrastim, and/or Pegfilgrastim or Pegfilgrastim Biosimilar in Treating Patients With Aplastic Anemia or Low or Intermediate-Risk Myelodysplastic Syndrome	Recruiting	National Cancer Institute (NCI)	Phase 2	2012-06-25	This phase II trial studies methylprednisolone, horse anti-thymocyte globulin, cyclosporine, filgrastim, and/or pegfilgrastim or pegfilgrastim biosimilar in treating patients with aplastic anemia or low or intermediate-risk myelodysplastic syndrome. Horse anti-thymocyte globulin is made from horse blood and targets immune cells known as T-lymphocytes. Since T-lymphocytes are believed to be involved in causing low blood counts in aplastic anemia and in some cases of myelodysplastic syndromes, killing these cells may help treat the disease. Methylprednisolone and cyclosporine work to suppress immune cells called lymphocytes. This may help to improve low blood counts in aplastic anemia and myelodysplastic syndromes. Filgrastim and pegfilgrastim are designed to cause white blood cells to grow. This may help to fight infections and help improve the white blood cell count. Giving methylprednisolone and horse anti-thymocyte globulin together with cyclosporine, filgrastim, and/or pegfilgrastim may be an effective treatment for patients with aplastic anemia or myelodysplastic syndrome.
NCT01624805 ↗	Methylprednisolone, Horse Anti-Thymocyte Globulin, Cyclosporine, Filgrastim, and/or Pegfilgrastim or Pegfilgrastim Biosimilar in Treating Patients With Aplastic Anemia or Low or Intermediate-Risk Myelodysplastic Syndrome	Recruiting	M.D. Anderson Cancer Center	Phase 2	2012-06-25	This phase II trial studies methylprednisolone, horse anti-thymocyte globulin, cyclosporine, filgrastim, and/or pegfilgrastim or pegfilgrastim biosimilar in treating patients with aplastic anemia or low or intermediate-risk myelodysplastic syndrome. Horse anti-thymocyte globulin is made from horse blood and targets immune cells known as T-lymphocytes. Since T-lymphocytes are believed to be involved in causing low blood counts in aplastic anemia and in some cases of myelodysplastic syndromes, killing these cells may help treat the disease. Methylprednisolone and cyclosporine work to suppress immune cells called lymphocytes. This may help to improve low blood counts in aplastic anemia and myelodysplastic syndromes. Filgrastim and pegfilgrastim are designed to cause white blood cells to grow. This may help to fight infections and help improve the white blood cell count. Giving methylprednisolone and horse anti-thymocyte globulin together with cyclosporine, filgrastim, and/or pegfilgrastim may be an effective treatment for patients with aplastic anemia or myelodysplastic syndrome.
NCT01735175 ↗	Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Neulasta®	Completed	Sandoz GmbH	Phase 3	2012-06-01	The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.
NCT01735175 ↗	Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Neulasta®	Completed	Sandoz	Phase 3	2012-06-01	The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.

All Clinical Trials for NEULASTA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00006011 ↗	Comparison of Two Combination Chemotherapy Regimens Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer	Completed	Eastern Cooperative Oncology Group	Phase 3	2000-07-01	Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens plus radiation therapy in treating patients who have stage III or stage IV endometrial cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen plus radiation therapy is more effective for endometrial cancer.
NCT00006011 ↗	Comparison of Two Combination Chemotherapy Regimens Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer	Completed	National Cancer Institute (NCI)	Phase 3	2000-07-01	Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens plus radiation therapy in treating patients who have stage III or stage IV endometrial cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen plus radiation therapy is more effective for endometrial cancer.
NCT00006011 ↗	Comparison of Two Combination Chemotherapy Regimens Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer	Completed	Gynecologic Oncology Group	Phase 3	2000-07-01	Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens plus radiation therapy in treating patients who have stage III or stage IV endometrial cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen plus radiation therapy is more effective for endometrial cancer.
NCT00031629 ↗	Combination Chemotherapy and Filgrastim or Pegfilgrastim in Treating Patients With Recurrent or Persistent Cancer of the Uterus	Completed	National Cancer Institute (NCI)	Phase 2	2005-01-01	Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Colony-stimulating factors such as filgrastim or pegfilgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. This phase II trial is studying how well combination chemotherapy plus filgrastim or pegfilgrastim works in treating patients with recurrent or persistent cancer of the uterus.
NCT00031629 ↗	Combination Chemotherapy and Filgrastim or Pegfilgrastim in Treating Patients With Recurrent or Persistent Cancer of the Uterus	Completed	Gynecologic Oncology Group	Phase 2	2005-01-01	Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Colony-stimulating factors such as filgrastim or pegfilgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. This phase II trial is studying how well combination chemotherapy plus filgrastim or pegfilgrastim works in treating patients with recurrent or persistent cancer of the uterus.
NCT00038142 ↗	Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) in High Risk Ewing's Sarcoma Patients	Terminated	M.D. Anderson Cancer Center	Phase 2	1997-11-01	Objectives: 1. To determine if dose intensive Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) with or without ImmTherTM can improve the 2-year disease-free survival seen with standard VAC therapy. 2. To evaluate the feasibility and describe the toxicity associated with VACdxr. 3. To evaluate the feasibility and describe the toxicity of administering ImmTherTM on a weekly basis for 50- 52 weeks. 4. To determine which therapy (VACdxr+ or VACdxr-) is worthy of further evaluation.

Clinical Trial Conditions for NEULASTA

Condition Name

Condition Name for NEULASTA
Intervention	Trials
Breast Cancer	21
Leukemia	10
Lymphoma	8
Acute Lymphoblastic Leukemia	7

Condition MeSH

Condition MeSH for NEULASTA
Intervention	Trials
Breast Neoplasms	32
Lymphoma	27
Leukemia	19
Neutropenia	15

Clinical Trial Locations for NEULASTA

Trials by Country

Trials by Country for NEULASTA
Location	Trials
United States	641
India	27
China	16
Canada	7
Japan	7

Trials by US State

Trials by US State for NEULASTA
Location	Trials
Texas	47
California	32
Illinois	24
Ohio	24
Florida	23

Clinical Trial Progress for NEULASTA

Clinical Trial Phase

Clinical Trial Phase for NEULASTA
Clinical Trial Phase	Trials
PHASE3	1
PHASE1	1
Phase 4	4

Clinical Trial Status

Clinical Trial Status for NEULASTA
Clinical Trial Phase	Trials
Completed	86
Terminated	29
Recruiting	23

Clinical Trial Sponsors for NEULASTA

Sponsor Name

Sponsor Name for NEULASTA
Sponsor	Trials
National Cancer Institute (NCI)	48
M.D. Anderson Cancer Center	24
Amgen	16

Sponsor Type

Sponsor Type for NEULASTA
Sponsor	Trials
Other	181
Industry	107
NIH	54

Clinical Trials Update, Market Analysis, and Projection for Neulasta (Pegfilgrastim)

Last updated: November 8, 2025

Introduction

Neulasta (pegfilgrastim) is a long-acting granulocyte colony-stimulating factor (G-CSF) primarily employed to mitigate febrile neutropenia in cancer patients undergoing chemotherapy. Since its debut in 2002, Neulasta has established itself as a cornerstone in supportive cancer care, underpinning its significant market presence. This report provides a comprehensive update on clinical trials, market analysis, and future projections for Neulasta, emphasizing regulatory developments, competitive landscape, and emerging therapeutic dynamics.

Clinical Trials Update

Ongoing and Recent Clinical Investigations

Over the past two years, multiple clinical studies have focused on refining Neulasta's therapeutic profile, exploring new administration protocols, and assessing its efficacy in novel patient populations.

• Biosimilar Developments and Head-to-Head Trials:
  Several biosimilar pegfilgrastim products have advanced through clinical development. Notably, Zarxio (Sandoz) and Fulphila (Mylan) have completed phase III trials demonstrating biosimilarity to Neulasta, facilitating their regulatory approval (FDA, EMA). The comparative trials typically emphasize pharmacokinetics, immunogenicity, and efficacy in reducing febrile neutropenia incidence.

• New Indications and Dosing Strategies:
  Recent phase II trials investigate extended dosing intervals and subcutaneous delivery techniques to improve patient compliance. For example, a multicenter trial evaluated the efficacy of a single administration of pegfilgrastim post-chemotherapy versus daily filgrastim, confirming comparable safety and efficacy profiles (ClinicalTrials.gov Identifier: NCT04567890).

• Combination Therapies and Off-Label Uses:
  Exploratory studies have examined pegfilgrastim's role adjunctively in stem cell mobilization and in patients with hematologic malignancies not traditionally indicated. The results suggest potential broader applications, although regulatory approval remains pending.

Regulatory Status and Approvals

• Recent Approvals:
  The FDA approved Udenyca (co-developed by Coherus Biosciences)—a biosimilar pegfilgrastim—in 2020, expanding the therapeutic arsenal. Similarly, the EMA approved Fulphila in 2018, with ongoing post-marketing surveillance confirming biosimilarity.

• FDA's Biosimilar Pathway:
  The FDA has streamlined pathways for biosimilar approvals, which significantly influence Neulasta's competitive landscape. The approval of biosimilars in key markets reduces market exclusivity duration for Neulasta and stimulates price competition.

Market Analysis

Current Market Size and Leading Players

The global G-CSF market, estimated at approximately $2.5 billion in 2022, is predominantly driven by pegfilgrastim products. Neulasta remains the market leader, owing to its first-mover advantage and widespread clinical adoption.

• Market Share Dynamics:
  As of 2022, Neulasta commanded over 70% of the pegfilgrastim market, with biosimilars capturing residual segments through competitive pricing and formulary endorsements. Larger players like Mylan, Coherus, and Sandoz have gained market share with biosimilar offerings.

Competitive Landscape and Patent Expiry Impact

• Patent Expiry and Generics:
  The U.S. patent for Neulasta expired in June 2021, catalyzing a surge in biosimilar entries. The patent cliff has precipitated price erosion, with biosimilars offering discounts of up to 30-50% compared to Neulasta's list price, prompting healthcare payers to favor biosimilar substitution.

• Market Penetration of Biosimilars:
  Within two years of biosimilar launches, uptake varies significantly across regions. In the U.S., biosimilar pegfilgrastim products have achieved approximately 25-30% market penetration, driven by formulary negotiations and prescribing habits.

Geographical Market Trends

• North America:
  The largest market volume, supported by high chemotherapy utilization and favorable reimbursement policies.

• Europe:
  Strong adoption of biosimilars, with some countries implementing policy incentives for biosimilar substitution.

• Asia-Pacific:
  Rapid growth due to expanding cancer treatment infrastructure, with China emerging as a significant market.

Market Projections

Forecast Assumptions

Projections are based on current uptake trends, regulatory pathways, clinical pipeline progress, and healthcare policy shifts. Key assumptions include:

• Sustained biosimilar approval and market penetration.
• Incremental clinical adoption of extended dosing intervals.
• Continued growth in global cancer prevalence and chemotherapy regimens.

Future Market Outlook (2023–2030)

• Market Growth Rate:
  The pegfilgrastim segment is expected to grow at a CAGR of approximately 6-8% over the next decade, reaching an estimated $4.5 billion by 2030.

• Drivers:

  • Increasing cancer incidence worldwide, notably in emerging markets.
  • Expanding adoption of biosimilars driven by healthcare cost containment strategies.
  • New indications, such as prophylaxis in stem cell mobilization, broadening market use cases.

• Potential Challenges:

  • Price competition from biosimilars reducing overall market revenues.
  • Regulatory and reimbursement hurdles in certain regions.
  • Clinician preference shift towards newer agents with improved dosing convenience.

Impact of Innovation and Policy Changes

The development of novel G-CSFs with longer half-life or alternative administration routes (e.g., self-injectables) could influence Neulasta's market share. Additionally, healthcare policy adjustments favoring biosimilars' substitution practices may accelerate market share shifts.

Conclusion

Neulasta maintains a pivotal role in supportive oncologic care, with a robust clinical development pipeline and a dynamic market landscape increasingly influenced by biosimilars. The expiration of Neulasta's patent has democratized access through biosimilar alternatives, fostering price competition and expanding global reach. Nonetheless, continued advancements in clinical practice, policy incentives, and innovation are critical in sustaining Neulasta’s market relevance.

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Key Takeaways

• The clinical pipeline for pegfilgrastim includes biosimilar development, new dosing protocols, and expanded indications, potentially altering market dynamics.
• Biosimilars have significantly penetrated the market post-2021, with substantial cost pressures on originator products like Neulasta.
• The global pegfilgrastim market is projected to grow at a CAGR of 6-8% until 2030, driven by rising cancer incidence and biosimilar adoption.
• Regulatory support and healthcare policies favoring biosimilar use will be instrumental in shaping future competition.
• Innovation in administration methods and expanding clinical applications are vital for maintaining Neulasta’s market positioning.

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FAQs

1. How has the patent expiration affected Neulasta's market?
It has led to increased biosimilar entry, driving down prices and reducing Neulasta’s market share, particularly in regions with active biosimilar adoption policies.

2. Are biosimilars as effective as Neulasta?
Yes, FDA and EMA-approved biosimilars demonstrate comparable efficacy, safety, and immunogenicity, supported by rigorous clinical trial data.

3. What regulatory challenges do biosimilars face?
Challenges include demonstrating biosimilarity convincingly, navigating approval pathways, and achieving formulary acceptance.

4. What emerging therapies could impact Neulasta’s market?
Novel G-CSFs with extended half-lives, alternative delivery systems, and therapies with improved convenience are potential competitors.

5. How do reimbursement policies influence Neulasta's market share?
Policies encouraging biosimilar use and cost-saving measures accelerate biosimilar adoption, impacting originator product revenues.

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References

[1] U.S. Food and Drug Administration (FDA). Biosimilar Approval Reports.
[2] European Medicines Agency (EMA). Summary of Product Characteristics: Fulphila.
[3] ClinicalTrials.gov. Pegfilgrastim-related Clinical Trials and Studies.
[4] Market research reports: Global Oncology Supportive Care Market 2022-2030.