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.
NCT06116734 ↗	Lapelga vs Gastrofil	Not yet recruiting	Lawson Health Research Institute	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.
NCT00002610 ↗	Chemotherapy With or Without Surgery, Radiation Therapy, or Stem Cell Transplantation in Treating Young Patients With Kidney Tumors	Completed	National Cancer Institute (NCI)	Phase 3	1996-01-01	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 chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which therapy regimen is most effective for treating patients with kidney tumors. PURPOSE: Phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy, surgery, and/or peripheral stem cell or bone marrow transplantation in treating young patients with kidney tumors.
NCT00002610 ↗	Chemotherapy With or Without Surgery, Radiation Therapy, or Stem Cell Transplantation in Treating Young Patients With Kidney Tumors	Completed	Children's Oncology Group	Phase 3	1996-01-01	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 chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which therapy regimen is most effective for treating patients with kidney tumors. PURPOSE: Phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy, surgery, and/or peripheral stem cell or bone marrow transplantation in treating young patients with kidney tumors.

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
Japan	7
Netherlands	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 exclusivity/IP-driven generic risks

Last updated: July 30, 2026

Neupogen (filgrastim) is an established biologic for neutropenia and chemotherapy-induced febrile neutropenia prophylaxis and treatment. Filgrastim faces structural competition from pegfilgrastim (originator and biosimilars) and from other granulocyte colony-stimulating factor (G-CSF) products. As a result, Neupogen’s market is typically constrained by (1) dosing convenience disadvantages versus pegfilgrastim and (2) payor preference for longer-acting alternatives. Patent and regulatory exclusivity for Neupogen vary by jurisdiction and by specific manufacturing/therapeutic-use and formulation claims, with biosimilar and generic filgrastim supply driven primarily through biosimilar development pathways in markets where filgrastim is no longer under effective originator exclusivity.

What clinical trials are currently updating for Neupogen (filgrastim)?

Primary clinical use areas

• Chemotherapy-induced neutropenia (CIN) prophylaxis and treatment
• Febrile neutropenia (FN) as supportive care
• Hematopoietic stem cell transplant (HSCT) mobilization and post-transplant neutrophil recovery
• Severe chronic neutropenia (congenital, idiopathic, cyclic)
• HIV-related neutropenia (where locally indicated)

Trial update reality check for filgrastim Most late-stage trials for long-standing filgrastim brands have shifted from proving baseline efficacy to addressing:

• sequencing with chemotherapy regimens,
• comparative outcomes versus other CSFs,
• real-world effectiveness and utilization patterns,
• safety monitoring in specific comorbidity subsets.

For a “clinical trials update” focused on new, material Phase 3/registrational readouts, the Neupogen brand is generally not associated with high-frequency new pivotal trials in the modern cycle; instead, ongoing activity is more commonly seen in post-approval studies and head-to-head studies conducted for biosimilar comparability or for guideline-aligned practice optimization.

How big is the Neupogen market and what is the revenue exposure by geography?

Market structure Filgrastim (including branded originators and biosimilar/“follow-on” products) competes inside the broader G-CSF market with:

• pegfilgrastim (long-acting)
• other biosimilar and next-generation CSFs depending on region

Revenue exposure drivers

• Switching to pegfilgrastim: payor programs often favor once-per-cycle dosing for convenience
• Hospital procurement practices: tender dynamics can swing volume toward the lowest net-cost SKU
• Biosimilar adoption: as biosimilar penetration rises, originator brand share typically declines
• Indication mix: HSCT and certain institutional protocols can support ongoing demand for daily filgrastim

Geographic sensitivity

• US: reliance on biosimilar market dynamics and uptake
• EU/UK: national tendering and biosimilar uptake patterns are decisive
• Emerging markets: penetration depends on reimbursement and biosimilar availability rather than strict patent barriers

What is the competitive landscape for Neupogen versus pegfilgrastim and biosimilars?

Direct competitive substitutes

• Pegfilgrastim (originator and biosimilars): once-per-cycle dosing competes strongly in CIN prophylaxis
• Filgrastim biosimilars: compete on price and procurement rather than on differentiated pharmacology

Commercial positioning in formularies

• Neupogen is frequently positioned for settings where short-acting daily administration is acceptable or protocolized.
• Where payors impose step edits or prior authorization, pegfilgrastim-based regimens usually capture more scripts for CIN prophylaxis.

When does Neupogen lose exclusivity, and what patent/IP barriers affect biosimilar competition?

Executive answer Neupogen’s US originator patent exclusivity is no longer the dominant barrier in most scenarios; competition is primarily shaped by:

• the expiration and enforceability of relevant patents (including any method-of-use or manufacturing process claims that could still be asserted),
• biosimilar interchangeability and labeling,
• litigation outcomes that can delay certain launches in specific time windows.

Practical barrier types that matter

• Manufacturing/process claims: can restrict certain process variants even after basic composition coverage ends
• Method-of-use claims: may attach to specific dosing schedules or indication-specific use in jurisdictions where such claims remain asserted
• Device/dosing regimen claims: less common for classic filgrastim products but can matter for particular formulations or delivery approaches

What patents protect Neupogen filgrastim, and how many are still relevant to launch timing?

Executive answer A full, “how many patents still relevant” answer requires Orange Book style listing and/or jurisdictional patent register mapping to specific product presentations. Neupogen is a long-established biologic; the most business-relevant analysis in practice focuses on:

• whether any active, asserted patents cover non-obvious variants (process or use),
• whether any biosimilar entrants have been blocked or delayed by litigation or settlement.

Without a product-presentation level patent list and jurisdictional active status, a definitive count cannot be produced in a way that supports actionable launch or licensing decisions.

What is the FDA regulatory status of Neupogen (BLA/labeling, biosimilar landscape)?

Executive answer Neupogen is an FDA-approved filgrastim product with established labeling for neutropenia indications. FDA’s modern regulatory environment centers on:

• biosimilar approval pathways for filgrastim products,
• labeling comparability to reference filgrastim,
• post-marketing pharmacovigilance and lot-to-lot safety monitoring.

In commercial terms, the regulatory status that matters most is which filgrastim biosimilars have received approval in the same market and what tender formularies prefer.

What generic entry risks exist for Neupogen, including Paragraph IV for small molecules vs biosimilars?

Executive answer Paragraph IV is a small-molecule Hatch-Waxman construct and is generally not the framework for filgrastim biosimilars. The business-relevant risk profile for Neupogen hinges on:

• biosimilar approval and launch sequencing,
• litigation under the biologics pathway using the BPCIA framework,
• settlement-driven launch calendars,
• supply and interchangeability constraints by region.

How does Neupogen compare with other G-CSFs for outcomes and cost-effectiveness?

Outcome profile

• Filgrastim daily administration produces predictable neutrophil recovery.
• Pegfilgrastim offers dosing convenience and is often preferred for prophylaxis due to reduced administration visits.

Cost-effectiveness levers

• administration cost offsets (nurse time, infusion center vs home injection programs),
• payor adherence requirements,
• bundled oncology visit structures.

In many US payor models, the total cost of care favors pegfilgrastim once administration and adherence are accounted for, unless daily dosing is already embedded into a protocol or supply contract.

What is the clinical development pipeline for filgrastim products, and where are the likely next wins?

Pipeline focus areas that attract development activity

• biosimilar and interchangeability-enabling programs
• subpopulation safety monitoring and real-world effectiveness studies
• HSCT and mobilization protocols refinement
• adherence improvements via delivery options

Business implication For an established filgrastim brand, “next wins” usually come from procurement contracts and labeling alignment rather than new clinical breakthrough trials, unless a sponsor pursues a differentiated platform (delivery, dosing regimen, or new combination strategy).

Market projection for Neupogen: base case, downside, upside

Base case (most likely)

• Gradual brand share erosion versus pegfilgrastim and biosimilar filgrastim
• Revenue stability or mild decline depending on tender dynamics and access

Downside

• stronger payor shift to pegfilgrastim
• increased biosimilar penetration in hospital formularies
• supply substitution away from daily filgrastim in CIN prophylaxis pathways

Upside

• protocolized HSCT mobilization and post-transplant use that sustains daily filgrastim volumes
• favorable contract pricing that keeps Neupogen competitive versus biosimilar SKUs

Key clinical and commercial metrics to track for next 12-36 months

• Script share for CIN prophylaxis: proportion using filgrastim daily vs pegfilgrastim
• Hospital tender outcomes: awarded formulary positions and net price
• Biosimilar penetration in each geography: line-item share by SKU
• Real-world FN hospitalization reduction where reported: outcome validation for payor retention
• Supply continuity and lot availability: can shift volume irrespective of clinical outcomes

Key Takeaways

• Neupogen (filgrastim) remains a clinically established CSF for neutropenia management, but routine clinical development is typically not centered on new pivotal trials for the originator brand.
• Market performance is primarily driven by payor and hospital preference for longer-acting pegfilgrastim and by biosimilar price competition in the filgrastim category.
• Exclusivity and IP barriers are usually not the dominant determinant of launch timing in current practice; competition calendars are more often shaped by biosimilar approvals and litigation/settlement outcomes rather than fresh originator exclusivity.
• The most actionable forward-looking view is to monitor tender outcomes, biosimilar share gains, and prophylaxis mix shift toward pegfilgrastim.

FAQs

1. How does filgrastim dosing frequency affect hospital utilization versus pegfilgrastim?
2. Which Neupogen indications tend to retain daily filgrastim volume in practice?
3. Do biosimilar filgrastim launches typically reduce originator revenue immediately or after tender cycles?
4. What manufacturing or process-related IP issues most often delay biosimilar competition for filgrastim?
5. How do payer prior authorization criteria typically influence choice between filgrastim and pegfilgrastim?

References

1. FDA. “Neupogen (filgrastim) Prescribing Information.” FDA access data (most recent label on FDA Drugs@FDA).
2. FDA. “Biosimilars: Information about Biosimilar Products.” FDA webpages.
3. EMA. “Guideline on Similar Biological Medicinal Products.” EMA regulatory framework materials.