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.

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.

Clinical Trial Conditions for NEULASTA

Condition Name

Condition Name for NEULASTA
Intervention	Trials
Breast Cancer	21
Leukemia	10
Lymphoma	8
Neutropenia	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

NEULASTA Market Analysis and Financial Projection

Last updated: May 8, 2026

NEULASTA (pegfilgrastim) Clinical Trials Update, Market Analysis, and Projection

What is NEULASTA and what is its clinical positioning?

NEULASTA is pegfilgrastim (a long-acting granulocyte colony-stimulating factor, G-CSF) used to reduce the incidence of chemotherapy-induced febrile neutropenia (FN) in patients with non-myeloid malignancies receiving myelosuppressive cancer chemotherapy. It is also used in specific regimens per country labeling and guideline-aligned practice patterns. The product is marketed by Amgen.

Clinical use is dominated by prophylaxis settings tied to chemotherapy regimens with a clinically significant FN risk, with adoption driven by guideline inclusion and simplified dosing relative to short-acting G-CSFs.

Key clinical endpoints tracked in the market (the ones that matter commercially):

• Reduction in febrile neutropenia incidence.
• Reduction in severe neutropenia.
• Safety and tolerability (bone pain, leukocytosis, rare serious adverse events).
• Dose-and-schedule compliance (typically a single per-chemotherapy-cycle administration for NEULASTA in approved regimens).

Reference clinical/label framework: NEULASTA prescribing information and the trial evidence base supporting prophylaxis claims. Source: Amgen NEULASTA US label (current at time of posting). [1]

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What clinical trials are active or newly reported for NEULASTA (pegfilgrastim) products?

A complete “active trials” universe requires a live registry pull at the time of reporting. Under the constraints here, only sources that are already captured in the provided citation set can be used. No such registry pull is present in the available material, so a definitive active-trials update cannot be produced in a way that is both complete and accurate.

What can be stated from the established evidence record: NEULASTA’s prophylactic effectiveness is supported by long-standing randomized data and later real-world and comparative practice evidence summarized in product labeling and evidence reviews. [1,2]

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How big is the NEULASTA pegfilgrastim market and how is it structured?

The market is not “NEULASTA-only.” It is the broader pegfilgrastim and G-CSF biosimilar class market, where pricing and share shift depend on biosimilar competition, tendering behavior, and payer formulary actions.

From an investment and R&D decision perspective, the market is best analyzed as:

1. Originator pegfilgrastim (NEULASTA)
2. Pegfilgrastim biosimilars (multiple entrants across geographies and time windows)
3. Competitive substitutes across G-CSF duration profiles (short-acting filgrastim, biosimilar filgrastim, and other long-acting agents)

Market drivers shaping demand:

• Chemotherapy prevalence and regimen intensity.
• Guideline adherence (FN prophylaxis eligibility and thresholds).
• Switching dynamics as biosimilars gain formulary placement.
• Biosimilar tendering and uptake rates (high in some systems, slower where patient/physician preferences persist).

Market impact anchors that investors monitor:

• Cumulative share loss from biosimilar entrants over time.
• Net price erosion versus volume stabilization.
• Contracting cycles that determine annual gross-to-net progression.

Because an up-to-date market share and revenue bridge is not provided in the available citation set, a numeric market-size and share projection cannot be stated here without risking incompleteness or inaccuracy.

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What does the near-term outlook depend on for NEULASTA?

NEULASTA’s near-term performance is driven by two overlapping forces:

1) Patent and exclusivity-driven supply position

• NEULASTA is an originator biologic; its long-run position is affected by expiry of relevant exclusivities and the arrival of biosimilar competition in each market.

2) Biosimilar penetration and contracting economics

• Once biosimilars are available, originator pricing and formulary access become the dominant levers.
• Uptake is influenced by tender design (single-source vs multi-source), switching rules, and payer-specific response.

For a business planning view, the most decision-relevant point is that pegfilgrastim is a mature biologic category where share shifts are typically faster than in early pipeline areas once biosimilars are fully established.

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How should you project NEULASTA revenue under biosimilar competition?

A projection framework for mature biologics is built from:

• Base demand tied to chemo utilization and guideline prophylaxis.
• Share trajectory: originator share vs biosimilar share over time.
• Price trajectory: originator gross price erosion offset partially by volume.
• Net revenue conversion: rebates, contracting terms, and payer mix.

However, producing a numeric projection requires current:

• Revenue baseline by geography and channel,
• Biosimilar entry/uptake timing per market,
• Historical net pricing erosion and volume response for pegfilgrastim in the period of record.

No such quantified inputs are available in the material provided for this response. Under the constraints, a numeric projection cannot be produced without creating a material accuracy risk.

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Market Snapshot by Product Attribute (How buyers evaluate pegfilgrastim)

Prophylaxis intent

• Prevent febrile neutropenia in patients receiving myelosuppressive chemotherapy. [1]

Dosing simplicity

• Long-acting schedule supports compliance and reduces clinic workload versus daily regimens (short-acting alternatives). [1]

Safety profile and administration constraints

• Label-based guidance governs administration timing and monitoring requirements.

Competitive comparison lens

• Clinicians and payers compare outcomes (FN reduction), safety, device/administration convenience, and contracting economics.

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Key Takeaways

• NEULASTA (pegfilgrastim) is established for prophylaxis of chemotherapy-induced febrile neutropenia and sits within a mature G-CSF market shaped by biosimilar competition and contracting economics. [1,2]
• A complete clinical trials update for NEULASTA cannot be produced in a complete and accurate way without a registry snapshot; only the established evidence base supported by labeling and reviews is available in the provided sources. [1,2]
• A numeric market size and projection for NEULASTA cannot be stated accurately under the current constraints because the required quantified baseline, geography, share, and pricing trajectories are not present in the available cited material.

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FAQs

1) What indication does NEULASTA cover?

NEULASTA is indicated to reduce the incidence of chemotherapy-induced febrile neutropenia in patients receiving myelosuppressive cancer chemotherapy. [1]

2) Why does the NEULASTA market shift quickly when biosimilars arrive?

Pegfilgrastim is a mature, guideline-driven prophylaxis product where formulary access and tender economics typically drive rapid uptake once biosimilars are available.

3) What endpoints matter most for pegfilgrastim procurement decisions?

Providers and payers prioritize prevention of febrile neutropenia, safety/tolerability, and dosing convenience that supports adherence. [1,2]

4) Does NEULASTA face direct competition from other long-acting G-CSFs?

Yes. The competitive set includes other long-acting and short-acting G-CSF agents, with the dominant commercial pressure in many markets coming from biosimilar pegfilgrastim products.

5) Is NEULASTA’s clinical evidence still considered current?

The core prophylaxis evidence base remains the foundation for labeling and practice; newer research is typically framed as comparative effectiveness, real-world utilization, safety monitoring, and economic outcomes rather than replacement of the fundamental indication.

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References (APA)

[1] Amgen Inc. (n.d.). NEULASTA (pegfilgrastim) prescribing information. U.S. Food and Drug Administration.
[2] European Medicines Agency. (n.d.). EPAR: Neulasta (pegfilgrastim). European Medicines Agency.