CLINICAL TRIALS PROFILE FOR FILGRASTIM

Biosimilar Clinical Trials for filgrastim

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.
NCT01542944 ↗	TevaGastrim for Stem Cell Mobilization Sibling Donors	Completed	Sheba Medical Center	Phase 2	2012-02-01	The aim of this study is to evaluate the efficacy of TevaGastrim which is a biosimilar version of Filgrastim recombinant human G-CSF (G-CSF) in mobilizing sufficient number of stem cells from normal sibling donors for allogeneic stem cell transplantation.
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.
NCT02806791 ↗	Efficacy of Biosimilar Filgrastim on the Mobilization of Hematopoietic Stem Cell CD34+ (Cluster of Differentiation 34) and on the Kinetic Engraftment	Unknown status	Azienda Ospedaliera San Giovanni Battista		2016-05-01	The endogenous growth factor granulocyte (G-CSF) stimulates the proliferation and differentiation of hematopoietic progenitors commissioned to mature as neutrophils and activated granulocytes mature neutrophils. In the field of hematology oncology G-CSF it is used to reduce the duration and complications of chemotherapy-induced neutropenia and to stimulate the mobilization and subsequent collection of circulating hematopoietic stem cells in order to use them for autologous transplantation procedure. Filgrastim and Lenograstim originator are marketed for many years and are considered the reference molecules for the production of biosimilar. For several years it is available and entered into common clinical practice the use of filgrastim biosimilar (Bio-GCSF) in treating the patient oncohematologic. Aim of the study is to analyze retrospectively a large series of patients and assess the impacts of the Bio-GCSF on the collection of hematopoietic stem cells and recovery of blood counts post autologous transplantation; the data will be compared with a historical cohort of reference that has been treated with G-CSF originator. The study results will not generate any diagnostic or therapeutic intervention in patients still alive.

All Clinical Trials for filgrastim

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000626 ↗	Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease	Completed	Amgen	Phase 2	1969-12-31	Primary: To assess the toxicity of chemotherapy with ABVD (doxorubicin / bleomycin / vinblastine / dacarbazine) when given with filgrastim ( granulocyte colony-stimulating factor; G-CSF ) in patients with underlying HIV infection and Hodgkin's disease; to observe the efficacy of ABVD and G-CSF in reducing tumor burden in HIV-infected patients with Hodgkin's disease. Secondary: To determine the durability of tumor response to ABVD plus G-CSF over the 2-year study period; to observe the incidence of bacterial and opportunistic infections in HIV-infected patients with Hodgkin's disease receiving this regimen; to document quality of life of patients receiving this regimen. Addition of granulocyte colony-stimulating factor may prevent neutropenia caused by chemotherapy, allowing more timely administration of chemotherapy and improved response.
NCT00000626 ↗	Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	Primary: To assess the toxicity of chemotherapy with ABVD (doxorubicin / bleomycin / vinblastine / dacarbazine) when given with filgrastim ( granulocyte colony-stimulating factor; G-CSF ) in patients with underlying HIV infection and Hodgkin's disease; to observe the efficacy of ABVD and G-CSF in reducing tumor burden in HIV-infected patients with Hodgkin's disease. Secondary: To determine the durability of tumor response to ABVD plus G-CSF over the 2-year study period; to observe the incidence of bacterial and opportunistic infections in HIV-infected patients with Hodgkin's disease receiving this regimen; to document quality of life of patients receiving this regimen. Addition of granulocyte colony-stimulating factor may prevent neutropenia caused by chemotherapy, allowing more timely administration of chemotherapy and improved response.
NCT00000801 ↗	Phase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System Lymphoma	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To estimate the response rate, overall and disease-free survival, toxicities, factors associated with outcome, and effect on quality of life in patients with AIDS-related primary CNS lymphoma treated with CHOD (cyclophosphamide, doxorubicin, vincristine, and dexamethasone) plus filgrastim (granulocyte-colony stimulating factor; G-CSF) and external beam irradiation. To determine other clinical markers present in this patient population. Combined modality therapy may prove of benefit for patients with AIDS-related primary CNS lymphoma.
NCT00000899 ↗	A Study on the Effect of Chemotherapy Combined With Anti-HIV Drugs in HIV-Positive Patients	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	The purpose of this study is to determine the safety of anti-HIV drugs combined with low-dose chemotherapy (consisting of cyclophosphamide [CTX]) in HIV-positive patients. This study examines whether this combination therapy can reduce the number of HIV-infected cells hidden in the lymph nodes and blood. Current anti-HIV drug treatments can greatly reduce the levels of HIV in the human body. However, HIV can hide in certain immune cells and escape the drugs' effects. Chemotherapy using CTX destroys these immune cells. When used with standard anti-HIV drug treatments, CTX may be able to speed up the elimination of HIV-infected cells.
NCT00001048 ↗	Comparison of Anti HIV Drugs Used Alone or in Combination With Cytosine Arabinoside to Treat Progressive Multifocal Leukoencephalopathy (PML) in HIV-Infected Patients	Completed	Bristol-Myers Squibb	Phase 2	1969-12-31	To compare the safety and efficacy of antiretroviral therapy (zidovudine plus either didanosine or dideoxycytidine) versus antiretroviral therapy plus intravenous cytarabine (Ara-C) versus antiretroviral therapy plus intrathecal Ara-C in the maintenance or improvement of neurological function over 6 months in HIV-infected individuals who have developed progressive multifocal leukoencephalopathy (PML). To compare the effect of these three treatment regimens on Karnofsky score and MRI studies. The effectiveness of Ara-C in the treatment of PML, caused by a human DNA papovavirus (designated JC virus) infection, has not been determined, although the most encouraging results have occurred with intrathecal administration of the drug.
NCT00001048 ↗	Comparison of Anti HIV Drugs Used Alone or in Combination With Cytosine Arabinoside to Treat Progressive Multifocal Leukoencephalopathy (PML) in HIV-Infected Patients	Completed	Upjohn	Phase 2	1969-12-31	To compare the safety and efficacy of antiretroviral therapy (zidovudine plus either didanosine or dideoxycytidine) versus antiretroviral therapy plus intravenous cytarabine (Ara-C) versus antiretroviral therapy plus intrathecal Ara-C in the maintenance or improvement of neurological function over 6 months in HIV-infected individuals who have developed progressive multifocal leukoencephalopathy (PML). To compare the effect of these three treatment regimens on Karnofsky score and MRI studies. The effectiveness of Ara-C in the treatment of PML, caused by a human DNA papovavirus (designated JC virus) infection, has not been determined, although the most encouraging results have occurred with intrathecal administration of the drug.
NCT00001048 ↗	Comparison of Anti HIV Drugs Used Alone or in Combination With Cytosine Arabinoside to Treat Progressive Multifocal Leukoencephalopathy (PML) in HIV-Infected Patients	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To compare the safety and efficacy of antiretroviral therapy (zidovudine plus either didanosine or dideoxycytidine) versus antiretroviral therapy plus intravenous cytarabine (Ara-C) versus antiretroviral therapy plus intrathecal Ara-C in the maintenance or improvement of neurological function over 6 months in HIV-infected individuals who have developed progressive multifocal leukoencephalopathy (PML). To compare the effect of these three treatment regimens on Karnofsky score and MRI studies. The effectiveness of Ara-C in the treatment of PML, caused by a human DNA papovavirus (designated JC virus) infection, has not been determined, although the most encouraging results have occurred with intrathecal administration of the drug.

Clinical Trial Conditions for filgrastim

Condition Name

Condition Name for filgrastim
Intervention	Trials
Lymphoma	217
Leukemia	192
Breast Cancer	85
Myelodysplastic Syndromes	69

Condition MeSH

Condition MeSH for filgrastim
Intervention	Trials
Lymphoma	292
Leukemia	271
Myelodysplastic Syndromes	126
Multiple Myeloma	123

Clinical Trial Locations for filgrastim

Trials by Country

Trials by Country for filgrastim
Location	Trials
United Kingdom	67
Hungary	9
Czech Republic	8
Norway	8
Russian Federation	8

Trials by US State

Trials by US State for filgrastim
Location	Trials
New York	282
California	280
Texas	273
Illinois	231
Ohio	219

Clinical Trial Progress for filgrastim

Clinical Trial Phase

Clinical Trial Phase for filgrastim
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	11
PHASE1	8

Clinical Trial Status

Clinical Trial Status for filgrastim
Clinical Trial Phase	Trials
Completed	684
Terminated	147
Unknown status	88

Clinical Trial Sponsors for filgrastim

Sponsor Name

Sponsor Name for filgrastim
Sponsor	Trials
National Cancer Institute (NCI)	578
M.D. Anderson Cancer Center	113
Children's Oncology Group	71

Sponsor Type

Sponsor Type for filgrastim
Sponsor	Trials
Other	1299
NIH	621
Industry	242

Filgrastim: Clinical Trials, Market Dynamics, and Future Outlook

Last updated: October 31, 2025

Introduction

Filgrastim, a recombinant granulocyte colony-stimulating factor (G-CSF), has become a cornerstone in managing neutropenia associated with chemotherapy, bone marrow transplantation, and certain medical conditions. Its ability to stimulate white blood cell production has secured its place in oncology supportive care, prompting ongoing clinical investigations, regulatory evolutions, and a dynamic market landscape. This report synthesizes recent clinical trial updates, analyzes market trends, and projects future growth trajectories for filgrastim.

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Recent Clinical Trials and Developmental Advances

Ongoing and Recent Clinical Studies

Over the past two years, several phase III and IV clinical studies have vaultingly advanced the understanding of filgrastim's efficacy, safety, and novel indications:

• Enhanced Supportive Care in Oncology: Multiple trials examine biosimilar formulations' non-inferiority and potential safety advantages, focusing on patient quality of life and cost reduction (e.g., Pfizer’s Zarxio and others). The BIOSIM trial, for instance, compared biosimilar filgrastim to innovator G-CSF, demonstrating equivalent efficacy in reducing severe neutropenia episodes [1].

• Extended Indications: Trials investigating filgrastim in non-oncologic domains include its role in severe congenital neutropenia and chemotherapy-induced neutropenia in pediatric populations. The NEST trial (Neutropenia Extended Support Trial) evaluates long-term hematologic recovery in immunocompromised pediatric subjects [2].

• Combination Therapies: Studies combining filgrastim with emerging immunotherapies, such as checkpoint inhibitors, explore potential synergistic effects, particularly in hematologic malignancies. Early-phase trials in the US and Europe are assessing safety profiles, with preliminary data endorsing combination feasibility [3].

• Gene Expression and Biomarker Studies: Recent research focuses on identifying biomarkers predicting patient response to filgrastim, facilitating personalized treatment. For instance, a recent publication identified certain cytokine profiles correlating with improved neutrophil recovery post-administration [4].

Regulatory and Labeling Updates

Regulatory bodies like the FDA and EMA continue to endorse filgrastim’s expanded use. Notably, the approval of biosimilars has reshaped market entry and competition dynamics, with agencies emphasizing robust analytical similarity and clinical data in these approvals [5]. Some jurisdictions have expanded indications to include mobilization for stem cell collection and management in allogeneic transplants.

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Market Analysis

Market Size and Growth Drivers

The global filgrastim market was valued at approximately USD 3.5 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 7% through 2030 [6].

Key drivers include:

• Rising Cancer Incidences: According to GLOBOCAN, around 19.3 million new cancer cases were diagnosed worldwide in 2020, with chemotherapy-induced neutropenia being a common complication [7].

• Increased Adoption of Biosimilars: The expiration of patents for original filgrastim formulations has sparked biosimilar proliferation, lowering costs and expanding access. Biosimilar filgrastims account for nearly 65% of the market in North America and Europe, fueling volume growth [8].

• Advancements in Leukemia and Stem Cell Transplantation: Growing indications for stem cell mobilization and transplantation procedures drive demand. Filgrastim is standard in mobilizing peripheral blood stem cells, a process increasingly preferred over bone marrow harvests.

• COVID-19 Impact: The pandemic emphasized supportive care needs in immunocompromised patients, indirectly boosting demand for G-CSFs, including filgrastim. Ongoing research into managing COVID-19-associated neutropenia has also expanded its application.

Regional Market Dynamics

• North America: Dominates owing to high cancer prevalence, advanced healthcare infrastructure, and biosimilar uptake. The US’s robust regulatory environment supports approval and reimbursement pathways.

• Europe: Exhibiting rapid growth fueled by biosimilar penetration and expanded indications. The EMA’s proactive stance on biosimilar regulation fosters market entry.

• Asia-Pacific: Projects the highest CAGR (~10%) driven by increased healthcare investment, rising cancer burden, and strategic biosimilar adoption in India, China, and Japan.

• Rest of World: Emerging markets in Latin America, the Middle East, and Africa are seeing gradual adoption due to cost-conscious healthcare systems, with local production of biosimilars contributing significantly.

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Market Challenges and Competitive Landscape

Despite optimistic projections, some challenges temper growth:

• Pricing and Reimbursement Constraints: Variability in healthcare coverage impacts patient access, particularly in low- and middle-income countries.

• Biosimilar Market Competition: Market saturation from biosimilars, while reducing prices, compresses profit margins for manufacturers.

• Convenience and Novel Alternatives: Development of long-acting G-CSFs, such as pegfilgrastim, offers less frequent dosing, potentially replacing daily filgrastim in certain settings.

• Regulatory Barriers: Divergence in regulatory approval pathways and skepticism regarding biosimilar interchangeability limit widespread adoption in some markets.

Major industry players, including Amgen, Pfizer, Sandoz (Novartis), and Celltrion, dominate the market, competing primarily through biosimilar offerings and strategic partnerships.

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Future Market Projections

Growth Outlook and Innovation Trends

The filgrastim market is positioned for steady growth, approaching USD 6.8 billion by 2030. Key drivers include:

• Personalized Medicine: Biomarker-based therapy stratification will optimize patient responses, possibly leading to customized dosing regimens.

• Long-Acting G-CSFs: Continued evolution towards less frequent dosing options, like pegfilgrastim, could cannibalize some filgrastim segments but also open new markets in treatment settings favoring low administration frequency.

• Emerging Therapeutic Applications: Ongoing research into filgrastim’s utility in viral recovery and immune-modulating roles could diversify applications, further expanding the market.

• Regulatory Harmonization: Streamlined approval pathways for biosimilars will foster market competitiveness and price reductions, spurring access in developing markets.

Key Takeaways

• Strong Clinical Evidence and Regulatory Support: Recent trials reinforce filgrastim’s efficacy and safety profile, bolstering ongoing market penetration and indication expansion.

• Biosimilar Market Growth: The proliferation of biosimilars is pivotal, reducing costs and increasing patient access, especially in high-burden regions.

• Regional Disparities and Opportunities: North America and Europe lead, yet Asia-Pacific presents high-growth potential due to demographic and healthcare infrastructure developments.

• Innovation and Market Evolution: Long-acting formulations and biomarker-driven therapies will shape future market dynamics, posing both challenges and opportunities.

• Strategic Focus: Companies that leverage robust clinical data, streamline regulatory pathways, and adapt to evolving treatment paradigms will secure competitive advantages.

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FAQs

1. What recent clinical developments have improved the therapeutic profile of filgrastim?
Recent trials have validated biosimilar equivalence, expanded indications in pediatric and non-oncologic neutropenia, and explored combinations with immunotherapies, broadening its application scope.

2. How has the biosimilar market influenced filgrastim’s global availability?
Biosimilars have increased market competition, driven down prices, and expanded access, especially in emerging markets, with regulatory bodies emphasizing analytical and clinical comparability.

3. What are the principal growth drivers for the filgrastim market through 2030?
Increasing cancer cases, rising stem cell transplant procedures, biosimilar adoption, and supportive care needs during the COVID-19 pandemic are key growth factors.

4. Which regions offer the highest future potential for filgrastim?
Asia-Pacific is projected to demonstrate the highest CAGR, driven by expanding healthcare investments and an increasing burden of hematologic diseases.

5. How might innovations in long-acting G-CSFs affect the filgrastim market?
Long-acting formulations like pegfilgrastim may displace daily filgrastim in some treatment protocols due to convenience, prompting industry players to innovate further for differentiation.

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Sources

[1] Clinical trial data on biosimilar G-CSFs, 2022.
[2] NEST trial protocol summary (2022).
[3] Early-phase combination therapy studies published in Hematology Reports, 2022.
[4] Biomarker research in neutropenia management, Journal of Hematology, 2022.
[5] FDA and EMA biosimilar approval guidelines, 2022.
[6] MarketResearch.com, Global G-CSF Market Report, 2023.
[7] GLOBOCAN 2020 Cancer Statistics.
[8] Biosimilar market expansion reports, Pharmaceutical Business Review, 2022.