CLINICAL TRIALS PROFILE FOR NEUPOGEN

Biosimilar Clinical Trials for NEUPOGEN

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

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT02098109 ↗	Non-inferiority Study of XM02 Filgrastim (Granix) and Filgrastim (Neupogen) in Combination With Plerixafor for Autologous Stem Cell Mobilization in Patients With Multiple Myeloma or Non-Hodgkin Lymphoma	Completed	Washington University School of Medicine	Phase 2	2014-08-20	This study will compare the results of stem cell mobilization using drugs called filgrastim (Neupogen) and plerixafor with the results of stem cell mobilization using drugs called XM02 filgrastim (Granix) and plerixafor.
NCT06116734 ↗	Lapelga vs Gastrofil	Not yet recruiting	Apobiologix.	Phase 3	2023-11-01	This study is examining one-time injection of biosimilar pegfilgrastim compared with multiple injection biosimilar filgrastim post autologous hematopoietic stem cell transplantation. Study aims to compare biosimilar pegfilgrastim - LaPelga and biosimilar filgrastim -Gastrofil to see if they are similar in efficacy in terms of neutrophil engraftment, limited adverse effects, and more convenience to our patients, with potential cost savings.

All Clinical Trials for NEUPOGEN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002524 ↗	Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma	Completed	National Cancer Institute (NCI)	Phase 2	1993-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with AIDS-related lymphoma.
NCT00002524 ↗	Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma	Completed	M.D. Anderson Cancer Center	Phase 2	1993-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with AIDS-related lymphoma.
NCT00002590 ↗	Combination Chemotherapy in Treating Children With Lymphoma	Completed	National Cancer Institute (NCI)	Phase 2	1994-07-01	RATIONALE: 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. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have lymphoma.
NCT00002590 ↗	Combination Chemotherapy in Treating Children With Lymphoma	Completed	Children's Oncology Group	Phase 2	1994-07-01	RATIONALE: 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. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have lymphoma.

Clinical Trial Conditions for NEUPOGEN

Condition Name

Condition Name for NEUPOGEN
Intervention	Trials
Leukemia	48
Lymphoma	41
Myelodysplastic Syndrome	22
Acute Myeloid Leukemia	21

Condition MeSH

Condition MeSH for NEUPOGEN
Intervention	Trials
Leukemia	98
Lymphoma	87
Leukemia, Myeloid, Acute	53
Leukemia, Myeloid	51

Clinical Trial Locations for NEUPOGEN

Trials by Country

Trials by Country for NEUPOGEN
Location	Trials
Canada	218
Australia	74
Puerto Rico	22
Netherlands	7
Japan	7

Trials by US State

Trials by US State for NEUPOGEN
Location	Trials
Texas	147
California	101
Illinois	79
New York	76
Washington	74

Clinical Trial Progress for NEUPOGEN

Clinical Trial Phase

Clinical Trial Phase for NEUPOGEN
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	8
Phase 3	58

Clinical Trial Status

Clinical Trial Status for NEUPOGEN
Clinical Trial Phase	Trials
Completed	199
Terminated	51
Recruiting	41

Clinical Trial Sponsors for NEUPOGEN

Sponsor Name

Sponsor Name for NEUPOGEN
Sponsor	Trials
National Cancer Institute (NCI)	189
M.D. Anderson Cancer Center	80
Children's Oncology Group	47

Sponsor Type

Sponsor Type for NEUPOGEN
Sponsor	Trials
Other	384
NIH	198
Industry	101

NEUPOGEN (filgrastim): Clinical Trials Update, Market Analysis and Price-Volume Projection

Last updated: April 29, 2026

What is NEUPOGEN and what products compete with it?

NEUPOGEN is filgrastim, a recombinant human G-CSF (granulocyte colony-stimulating factor) used to reduce the incidence of chemotherapy-induced febrile neutropenia (FN), and to support mobilization and collection of peripheral blood stem cells (PBSC). NEUPOGEN is also used in multiple settings where neutropenia risk is clinically relevant (per local labeling and guideline adoption). NEUPOGEN is a reference biologic; multiple biosimilar filgrastim products entered later across major markets.

Competing product classes (commercially relevant):

• Biosimilar filgrastim (multiple brands depending on geography)
• PEGylated filgrastim (pegfilgrastim) branded and biosimilar in many countries
• Other hematopoietic growth factors used in narrow indications (less direct for “standard” FN prevention)

Why this matters for market projections: pricing and share shift strongly between filgrastim dosing schedules (typically multiple injections) and pegfilgrastim (often single per-cycle dosing), while biosimilar competition compresses reference biologic price.

What does the current clinical landscape look like for NEUPOGEN (filgrastim)?

Are there new late-stage filings or pivotal modern trials that change the label?

No single new late-stage, label-defining clinical trial for filgrastim under the NEUPOGEN brand name is identifiable as a current market-shaping event from the publicly indexed corpus used for drug-development tracking. The NEUPOGEN story in mature markets is primarily governed by:

• Guideline-driven use (chemotherapy FN risk stratification, dose-dense regimens, and supportive care protocols)
• Biosimilar substitution and tender dynamics
• Ongoing comparative/operational evidence that supports clinician choice between filgrastim and pegfilgrastim

What trial types continue to move practice even without new pivotal endpoints?

Clinical activity in filgrastim typically clusters into four operational categories:

• Comparative efficacy and safety against other G-CSF regimens
• Dosing interval evaluations (including “real-world” adherence to schedule constraints)
• Special populations (e.g., transplant and hematologic settings)
• Stem cell mobilization protocols in PBSC workflows

Practical takeaway for R&D/BD

Filgrastim is a “mature molecule.” The highest ROI clinical work in this space typically targets:

• Protocol efficiencies (dose and schedule logistics to reduce administration burden)
• Comparative endpoints with payor-relevant endpoints (hospitalizations for FN, infusion suite utilization)
• Biosimilar differentiation where regulatory frameworks allow (process comparability evidence rather than novel pharmacology)

What is driving demand for NEUPOGEN?

Core demand engines

1. Chemotherapy-induced febrile neutropenia (FN) prevention
   Demand rises with chemotherapy volume, regimen intensity, and guideline adoption of primary prophylaxis for intermediate/high FN-risk regimens.

2. PBSC mobilization support
   Transplant centers and collection workflows drive consistent use.

3. Dose-dense and supportive care protocols
   Regimens that push neutrophil recovery on schedule increase reliance on G-CSF support.

Key headwinds

1. Biosimilar substitution of filgrastim
2. Switching from filgrastim to pegfilgrastim in cycle-based regimens where single-dose convenience reduces administration burden
3. Concentration of purchasing via tenders that favor the lowest-cost effective alternative

Market analysis: How does NEUPOGEN perform versus pegfilgrastim and filgrastim biosimilars?

Market structure

• Filgrastim sits in the “standard G-CSF” bucket where multiple biosimilars exist in most major regions.
• Pegfilgrastim competes directly where treatment teams prefer less frequent injections aligned to chemotherapy cycles.
• Price compression follows biosimilar entry: reference biologic share erodes even where clinical outcomes remain equivalent.

Competitive dynamics by buyer

• Hospitals and infusion centers: prioritize total administered dose and administration workload.
• National health systems: prioritize lowest acquisition cost under tender constraints.
• Private payors: balance drug cost against FN-related downstream costs (ER visits, hospital admissions).

Implications for NEUPOGEN

Even if clinical outcomes remain stable, NEUPOGEN’s commercial trajectory is mainly a share-and-price problem, not a “new science” problem.

Price-Volume projection: What is the likely 3-year trajectory?

Projection framework

This projection uses three standard drivers for mature biologics:

1. Volume growth is linked to chemotherapy market growth and transplant volumes, offset by protocol substitution to pegfilgrastim and biosimilars.
2. Price is pulled down by biosimilar substitution and tendering.
3. Share shifts from reference to lowest-cost effective filgrastim and to pegfilgrastim where convenience and protocols favor it.

Three-year outlook (directional but decision-grade)

Because NEUPOGEN is a mature reference filgrastim and because biosimilar and pegfilgrastim competition is established across major markets, the expected pattern is:

• Unit volume for NEUPOGEN declines as share erodes
• Net sales decline faster than units due to price compression

Baseline projection (global mature markets, 3-year horizon)

• Units: down low-to-mid single digits annually (share loss to biosimilars and substitution to pegfilgrastim)
• Net price: down mid-to-high single digits annually (tender pressure and mix shift)
• Net sales: down mid-to-high double digits cumulatively over 3 years

Scenario bounds (used for planning)

• Base case: NEUPOGEN net sales decline as biosimilar share gains continue and pegfilgrastim substitution continues in cycle-based regimens.
• Downside case: faster tender reallocation against NEUPOGEN reference product as contracts lock in lowest-cost entrants.
• Upside case: stable institutional formularies and slower substitution in transplant and high-complexity protocols.

Regulatory and guideline environment: What affects prescribing and reimbursement?

Guidelines

Use is anchored in supportive care guideline pathways that stratify FN risk by regimen intensity and patient factors. When guidelines recommend prophylaxis, G-CSF utilization increases and stabilizes the class market.

Regulatory substitution

In regions with biosimilar substitution policies or tender frameworks, reference biologic uptake declines even when clinical interchangeability is established.

What is the investment and competitive positioning takeaway?

For investors

• Filgrastim reference brands typically face structural unit share erosion after biosimilar entry.
• Returns depend on timing of competitive churn, contract wins in hospitals, and ability to maintain pricing through differentiated channels (where any exists).

For R&D/BD

If evaluating next-gen programs in the filgrastim/pegfilgrastim arena, the most fundable hypotheses usually target:

• Dosing convenience and reduced administration
• Operational endpoints that affect payor and hospital budgets
• Protocol-specific evidence that supports use in high-throughput settings

Key Takeaways

• NEUPOGEN is a mature reference G-CSF (filgrastim) whose market trajectory is driven by biosimilar substitution, tender dynamics, and switching to pegfilgrastim.
• Clinical activity remains mostly comparative and operational rather than new label-defining late-stage trials that reset the commercial outlook.
• Over a 3-year horizon in mature markets, NEUPOGEN is expected to show declining units and faster net sales decline due to price compression and share loss.

FAQs

1) Does NEUPOGEN face new clinical risk that could eliminate its core use?
No. The key risk is commercial substitution, not loss of efficacy or safety in established practice.

2) Why does pegfilgrastim usually take share from filgrastim?
Pegfilgrastim aligns with cycle-based administration, typically reducing injection burden and improving workflow convenience.

3) Do biosimilars reduce market size or mainly shift share and price?
They primarily shift share away from reference products and compress price, with limited net expansion of the overall class in mature settings.

4) What setting protects filgrastim reference brands the most?
High-standardized protocols and transplant/PBSC workflows where tender choices and formulary inertia may slow substitution, though this varies by market.

5) What outcome measures best track NEUPOGEN commercial health?
Net sales, effective price (post-tender), and hospital/system share trends; units alone can be misleading if mix and contract pricing change.

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References

1. National Comprehensive Cancer Network (NCCN). NCCN Guidelines for Supportive Care in Oncology (Neutropenia/Fever-Related Infections). Latest version accessed for guideline framework.
2. European Society for Medical Oncology (ESMO). EHA/ESMO supportive care guidance and updates on febrile neutropenia prophylaxis. Latest version accessed for guideline framework.
3. U.S. Food and Drug Administration (FDA). Biosimilar Product Information and Substitution Frameworks (for policy background affecting reference biologic market dynamics).
4. FDA. Guidance for Industry: Clinical Considerations for Biosimilar Submissions.