CLINICAL TRIALS PROFILE FOR PEGFILGRASTIM

Biosimilar Clinical Trials for pegfilgrastim

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.
NCT02768714 ↗	Trial to Compare the Efficacy and Safety of Pegfilgrastim Biosimilar in Subjects With High Risk Stage Breast Cancer Receiving Chemotherapy	Withdrawn	Eurofarma Laboratorios S.A.	Phase 3	2018-01-01	This is a Phase III, randomised, assessor-blind, parallel group, multicentre trial. At least 180 adult subjects with high-risk Stage II or Stage III / IV breast cancer will be randomised (1:1) to receive either Eurofarma's pegfilgrastim (n = 90) or Neulastim (n = 90) in 8 to 10 sites in Brazil. Subjects will undergo a maximum of 4 cycles of myelosuppressive chemotherapy (21 days per cycle).

All Clinical Trials for pegfilgrastim

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003955 ↗	Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Metastatic Rhabdomyosarcoma or Sarcoma	Completed	National Cancer Institute (NCI)	Phase 2	1999-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy combined with radiation therapy in treating patients who have metastatic rhabdomyosarcoma or sarcoma.
NCT00003955 ↗	Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Metastatic Rhabdomyosarcoma or Sarcoma	Completed	Children's Oncology Group	Phase 2	1999-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy combined with radiation therapy in treating patients who have metastatic rhabdomyosarcoma or sarcoma.
NCT00004192 ↗	Colony-Stimulating Factors to Relieve Neutropenia in Patients With Recurrent Non-Hodgkin's Lymphoma	Completed	National Cancer Institute (NCI)	Phase 2	2000-05-01	RATIONALE: Colony-stimulating factors 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. PURPOSE: Randomized phase II trial to compare the effectiveness of filgrastim-SD/01 with that of filgrastim to relieve the neutropenia following combination chemotherapy in patients who have non-Hodgkin's lymphoma.
NCT00004192 ↗	Colony-Stimulating Factors to Relieve Neutropenia in Patients With Recurrent Non-Hodgkin's Lymphoma	Completed	University of Nebraska	Phase 2	2000-05-01	RATIONALE: Colony-stimulating factors 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. PURPOSE: Randomized phase II trial to compare the effectiveness of filgrastim-SD/01 with that of filgrastim to relieve the neutropenia following combination chemotherapy in patients who have non-Hodgkin's lymphoma.
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.

Clinical Trial Conditions for pegfilgrastim

Condition Name

Condition Name for pegfilgrastim
Intervention	Trials
Breast Cancer	53
Lymphoma	31
Neutropenia	19
Leukemia	18

Condition MeSH

Condition MeSH for pegfilgrastim
Intervention	Trials
Lymphoma	75
Breast Neoplasms	71
Neutropenia	35
Leukemia	29

Clinical Trial Locations for pegfilgrastim

Trials by Country

Trials by Country for pegfilgrastim
Location	Trials
Canada	52
Australia	32
United Kingdom	28
China	24
France	16

Trials by US State

Trials by US State for pegfilgrastim
Location	Trials
Texas	69
California	62
New York	57
Ohio	54
Illinois	51

Clinical Trial Progress for pegfilgrastim

Clinical Trial Phase

Clinical Trial Phase for pegfilgrastim
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	2
PHASE2	9

Clinical Trial Status

Clinical Trial Status for pegfilgrastim
Clinical Trial Phase	Trials
Completed	167
Recruiting	43
Terminated	41

Clinical Trial Sponsors for pegfilgrastim

Sponsor Name

Sponsor Name for pegfilgrastim
Sponsor	Trials
National Cancer Institute (NCI)	97
Amgen	39
M.D. Anderson Cancer Center	28

Sponsor Type

Sponsor Type for pegfilgrastim
Sponsor	Trials
Other	363
Industry	184
NIH	98

Pegfilgrastim Clinical Trials Update, Market Analysis, and Projection

Last updated: May 9, 2026

What is the pegfilgrastim clinical and regulatory status driving right now?

Pegfilgrastim (G-CSF) remains a mature, widely used biologic with a set of well-established delivery platforms. Clinical activity now clusters around (1) biosimilar development, (2) label expansions in hematologic malignancies and supportive care settings, and (3) formulation and dosing regimen refinement (notably on-body/injector and longer-acting schedules).

What trial updates matter most for competitive positioning?

Across recent years, development priorities for pegfilgrastim derivatives track three commercial outcomes: stronger payor positioning via dosing convenience, faster administration workflows, and reduced clinic burden. The “shape” of late-stage programs generally follows one of these patterns:

• Biosimilar efficacy and safety: program design centers on matching exposure, ANC recovery, and acute safety in chemotherapy-induced neutropenia settings.
• Convenience and administration: on-body injector and longer dosing intervals remain key differentiators for adoption and hospital workflow.
• Expanded supportive-care labels: activity tends to focus on additional chemotherapy regimens and patient subsets where neutropenia risk or management guidelines broaden use.

Evidence anchor: label framework (commercial baseline)

Pegfilgrastim is widely approved for reduction of incidence of infection manifested by febrile neutropenia in patients receiving myelosuppressive anti-cancer drugs (US labeling framework for filgrastim class supportive care). The competitive market does not hinge on whether pegfilgrastim is effective, but on how quickly and reliably it can be administered and reimbursed in routine practice.

Practical implication for a clinical-trials watchlist

A pegfilgrastim “update” that moves market expectations typically includes at least one of:

• A phase 3 (or bridging package that is accepted as equivalent) biosimilar readout.
• A label expansion that changes the eligible chemotherapy regimens or patient risk strata.
• New safety signals or meaningful differences in ANC recovery kinetics that affect provider protocols.

No single new mechanism or transformative efficacy shift is required to change adoption because the base standard of care is already stable. Changes that matter are operational and reimbursement-led.

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How big is the pegfilgrastim market, and what is the demand engine?

Pegfilgrastim’s market is driven by:

• Chemotherapy incidence across oncology, where febrile neutropenia risk triggers prophylaxis.
• Guideline adherence (risk-based prophylaxis rules in major markets).
• Hospital and payer protocols that favor products with simplified dosing and administration.

Demand segmentation that affects revenue forecasts

Market revenue is not uniform across segments. It shifts with chemotherapy mix, guideline strictness, and biosimilar uptake.

Common commercial segments:

• Prophylaxis in solid tumors receiving myelosuppressive chemotherapy.
• Prophylaxis in hematologic malignancies, where regimen intensity and neutropenia risk are higher.
• US versus EU adoption dynamics, strongly influenced by biosimilar procurement cycles.

Pricing and tender dynamics (what typically moves the curve)

Pegfilgrastim experiences price pressure primarily through:

• Biosimilar entry and tender-driven switching in oncology centers.
• Contracting behavior at large hospital systems and group purchasing organizations.
• Formulation preference (on-body vs prefilled syringe/needle-based) when administration workflow matters.

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Where is biosimilar competition most likely to accelerate?

Biosimilar penetration determines the longer-term revenue split among brands and generics/biosimilars. Penetration tends to accelerate where:

• Formularies and tender processes permit rapid switching.
• Clinician education and administration protocols reduce perceived substitution risk.
• Payer cost-effectiveness thresholds are triggered.

Competitive map (structure-level view)

The pegfilgrastim competitive set is typically characterized by:

• Original reference products (including on-body injector variants in some geographies)
• Biosimilars with phase 3 or bridging evidence
• Device-adjacent competitive positioning where injector convenience affects uptake

While specific product-by-product timelines can vary by geography, the market dynamic is consistent: biosimilars reduce the weighted average selling price (WASP) first, then volume share follows, and the gap narrows unless switching is constrained by contracting design.

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What is the market projection outlook for pegfilgrastim?

A defensible projection requires three levers: (1) volume growth (oncology incidence and guideline prophylaxis), (2) price erosion (biosimilar penetration and tender effects), and (3) mix shift between devices (on-body vs other forms).

Scenario framework used by investors

Pegfilgrastim forecasts are usually modeled as:

• Base-case: continued oncology demand growth with gradual WASP decline driven by biosimilar adoption.
• Downside: faster-than-expected switching and steeper tender discounts.
• Upside: slower adoption due to contracting inertia, protocol lock-in, or higher retention on injector convenience.

Projection direction (high-confidence qualitative direction)

• Revenue growth can be muted even when volume rises due to price erosion.
• Market growth rate in mature geographies depends on the pace of biosimilar share gains and any product preference effects (device and administration convenience).
• Longer-acting or injector workflows often hold share better during transitions, which can slow price erosion on the convenience segment.

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What clinical trial endpoints and readouts determine commercial outcomes?

For pegfilgrastim programs, the commercial impact of clinical evidence is tied to endpoints that translate into payer/provider confidence and protocol adoption.

Key readouts used in late-stage development

• ANC recovery kinetics (duration and depth of neutropenia)
• Incidence of febrile neutropenia (where studied)
• Safety: bone pain, hypersensitivity, injection-site events, and class-specific adverse events
• Pharmacokinetics: exposure matching and clearance behavior
• Device usability and administration workflow (for injector programs)

Why these endpoints matter commercially

• ANC recovery and febrile neutropenia prevention align directly with clinical protocols.
• Safety tolerability affects formulary acceptance when multiple options exist.
• PK/exposure matching supports biosimilar interchangeability and reduces payer friction.

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How should investors and R&D teams position around pegfilgrastim now?

R&D focus: differentiation is “delivery,” not “new biology”

In a mature G-CSF category, the margin for differentiation is narrower. Competitive strategies that tend to work focus on:

• Matching convenience outcomes (time-to-admin, reduced clinic burden)
• Reducing switching friction via clinical evidence packages that align with established endpoints
• Aligning with tender and contracting realities (pricing and delivery reliability)

Investment focus: watch contracting and market share moves

For pegfilgrastim, market share changes often precede visible pricing updates because procurement cycles can lock in cost structures quickly. The key investor signals are:

• Biosimilar procurement announcements in major hospital networks
• Tender awards by region and product form factor
• Label expansions that change eligible patient populations

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Key Takeaways

• Pegfilgrastim clinical development is largely consolidation and substitution: biosimilar programs and label or regimen refinements, with differentiation centered on delivery convenience and workflow.
• Market growth is constrained by maturity; revenue outlook depends on how fast biosimilar uptake accelerates and how much device/method preference slows switching.
• Projection models for pegfilgrastim are driven by three levers: oncology volume growth, WASP decline from biosimilars, and mix shifts between delivery formats.
• Commercially meaningful clinical evidence typically targets ANC recovery, febrile neutropenia prevention, class safety, PK matching, and device-related practicality.

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FAQs

1) What type of clinical evidence most directly impacts pegfilgrastim biosimilar adoption?
Phase 3 or bridging evidence aligned to ANC recovery and febrile neutropenia prevention, plus PK/exposure matching and class-consistent safety.

2) What is the biggest non-clinical driver of market share for pegfilgrastim?
Contracting and tender-based switching in hospitals and payer formularies, often reinforced by administration convenience.

3) Do device formats (on-body vs other delivery) change competitive outcomes?
Yes. When workflows favor injector-style administration, convenience can slow switching and reduce price erosion on that segment.

4) What endpoints matter most to payers and protocol committees?
ANC recovery kinetics, incidence of febrile neutropenia, and class-consistent safety, as these map to prophylaxis protocols and risk management rules.

5) How should forecasts treat mature category price erosion?
As a primary driver of revenue direction. Volume growth may not offset the weighted selling price decline during accelerated biosimilar uptake cycles.

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References

[1] FDA. Neulasta (pegfilgrastim) Prescribing Information. U.S. Food and Drug Administration.
[2] FDA. Neupogen (filgrastim) Prescribing Information. U.S. Food and Drug Administration.
[3] EMA. Neulasta (pegfilgrastim) Assessment history and EPAR materials. European Medicines Agency.
[4] National Comprehensive Cancer Network (NCCN). Guidelines for Prevention and Treatment of Cancer-Related Infections: Febrile Neutropenia Prophylaxis Recommendations. NCCN.
[5] ESMO. Guidelines for the management of febrile neutropenia and supportive care in cancer. European Society for Medical Oncology.