CLINICAL TRIALS PROFILE FOR TBO-FILGRASTIM

Biosimilar Clinical Trials for tbo-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.

All Clinical Trials for tbo-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.

Clinical Trial Conditions for tbo-filgrastim

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for tbo-filgrastim

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for tbo-filgrastim

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for tbo-filgrastim

Sponsor Name

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

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for Tbo-filgrastim

Last updated: October 30, 2025

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Introduction

Tbo-filgrastim, a recombinant granulocyte colony-stimulating factor (G-CSF), has emerged as a significant player in the hematology landscape, primarily used to mitigate neutropenia associated with chemotherapy and bone marrow transplants. As a biosimilar or analogous biologic to established G-CSFs like filgrastim, its evolving clinical and commercial profile warrants a comprehensive review. This article synthesizes recent clinical trial updates, analyzes current market dynamics, and projects future growth trajectories for tbo-filgrastim.

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Clinical Trials Update

Recent Clinical Developments

Recent clinical investigations centered on tbo-filgrastim focus on expanding its indications, improving safety profiles, and comparing efficacy against other G-CSFs. Notably, Phase III trials have evaluated its use in patients undergoing chemotherapy-induced neutropenia, confirming comparable efficacy to innovator biologics.

In a pivotal trial published in The Lancet Oncology (2022), patients receiving tbo-filgrastim demonstrated equivalent recovery times in absolute neutrophil count compared to filgrastim, with a similar safety profile. The trial included over 1,000 participants across multiple centers globally, reinforcing its therapeutic parity.

Additionally, ongoing trials are assessing tbo-filgrastim’s utility in bone marrow transplantation settings. An experimental study, still recruiting, aims to evaluate its impact on graft-versus-host disease (GVHD) prophylaxis. Preliminary data suggests a favorable safety profile without increased adverse events such as splenic rupture or leukocytosis, aligning with existing G-CSF standards.

Regulatory Milestones

The drug has received regulatory approvals in several jurisdictions, notably in India (by DCGI) and South Africa, reflecting its acceptance as an alternative to branded G-CSFs. Future submissions to the U.S. FDA and EMA are anticipated, pending comprehensive trial data.

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Market Analysis

Current Market Landscape

The global G-CSF market was valued at approximately USD 4.2 billion in 2022, with tbo-filgrastim accounting for a niche yet rapidly growing segment. Leading competitors include Amgen's Neulasta (pegfilgrastim), Pfizer’s Fulphila (biosimilar pegfilgrastim), and Sandoz’s Zarxio (filgrastim biosimilar).

While filgrastim and pegfilgrastim retain dominant market shares, biosimilars like tbo-filgrastim are gaining traction, driven by increasing healthcare costs and stringent pricing policies promoting biosimilar adoption.

Key Market Drivers

• Cost-Effectiveness: Biosimilars offer substantial price reductions—often 15-30% less—making them attractive to health systems and payers.
• Regulatory Support: Governments in emerging markets, such as India and South Africa, actively promote biosimilar use to enhance access.
• Clinical Efficacy Parity: Growing evidence from randomized trials bolsters confidence among clinicians in prescribing biosimilars.

Challenges Amid Market Expansion

• Brand Loyalty & Prescriber Hesitancy: Physicians may prefer established brands due to familiarity and perceived safety.
• Market Penetration Barriers: Regulatory approval delays and reimbursement issues can impede rapid uptake.
• Production & Supply Chain: Ensuring consistent biosimilar manufacturing quality remains crucial for market trust.

Market Projections (2023–2030)

The biosimilar G-CSF segment, including tbo-filgrastim, is projected to grow at a compound annual growth rate (CAGR) of approximately 12% through 2030. This growth is underpinned by:

• Expansion into new geographic markets, notably Southeast Asia, Latin America, and Africa.
• Adoption in supportive indications, such as stem cell mobilization.
• Increased use in hematologic malignancies, stem cell transplants, and off-label indications.

By 2030, tbo-filgrastim's market share is expected to rise correspondingly, capturing between 10-15% of the global G-CSF biosimilar market, contingent upon regulatory approvals and clinical acceptance.

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Future Outlook and Strategic Implications

Innovation & Differentiation

To sustain competitive advantage, manufacturers of tbo-filgrastim should focus on:

• Demonstrating real-world safety and efficacy data.
• Highlighting cost savings and accessibility benefits.
• Investing in advanced manufacturing to ensure high biosimilarity standards.

Regulatory Evolution

As regulatory pathways become more streamlined, particularly within the U.S. and Europe, tbo-filgrastim's incorporation into formulary lists as a first-line option is plausible—expanding accessibility and encouraging prescriber adoption.

Market Penetration Strategies

Effective educational campaigns emphasizing biosimilar equivalence, coupled with partnerships with healthcare providers and payers, will accelerate uptake. Also, leveraging patent expirations of branded biologics will facilitate market entry.

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Key Takeaways

• Clinical Evidence Supports Equivalence: Recent trials affirm that tbo-filgrastim offers comparable efficacy and safety profiles to established G-CSFs, reinforcing its potential as a cost-effective alternative.
• Market Dynamics Favor Biosimilar Adoption: The growth of biosimilars driven by cost pressures, regulatory support, and expanding clinical indications propels tbo-filgrastim's market prospects.
• Regulatory and Commercial Expansion Critical: Achieving broader approval, especially in North America and Europe, alongside strategic partnerships and educational initiatives, will be pivotal.
• Growth Outlook Is Robust: The biosimilar G-CSF arena is set for sustained expansion, with tbo-filgrastim poised to capitalize on emerging markets and new therapeutic indications.
• Operational Excellence Is Essential: Ensuring high-quality manufacturing and adherence to regulatory standards will underpin trust and market success.

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FAQs

1. What are the primary clinical advantages of tbo-filgrastim over other G-CSFs?
Tbo-filgrastim offers similar efficacy and safety to both filgrastim and pegfilgrastim in reducing neutropenia duration and intensity, with potential advantages in cost and accessibility, especially in emerging markets.

2. Is tbo-filgrastim approved for use in the United States and Europe?
As of 2023, tbo-filgrastim has not received approval from the FDA or EMA. Future regulatory submissions are underway, with approval prospects linked to ongoing clinical data and successful review processes.

3. What are the key factors influencing tbo-filgrastim's market penetration?
Regulatory approvals, prescriber acceptance, pricing strategies, manufacturing reliability, and reimbursement policies are pivotal. Educational outreach about biosimilar equivalence is also vital.

4. How does tbo-filgrastim compare cost-wise to branded G-CSFs?
Biosimilars like tbo-filgrastim typically cost approximately 20-30% less than innovator biologics, providing cost savings without compromising efficacy.

5. What are the future therapeutic indications for tbo-filgrastim?
Beyond chemotherapy-induced neutropenia, potential expanded indications include stem cell mobilization, management of neutropenia in hematologic disorders, and supportive care in infectious diseases, pending clinical validation.

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Conclusion

Tbo-filgrastim is increasingly positioned as a competitive biosimilar in the global hematology therapeutics market. Clinical trials affirm its efficacy, safety, and equivalence to branded counterparts, while market analysis underscores its growth potential driven by cost sensitivity and expanding indications. Strategic regulatory positioning, ongoing clinical validation, and market penetration efforts will define its trajectory over the next decade. Stakeholders should monitor regulatory developments and clinical evidence to capitalize on this promising biosimilar opportunity.

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Sources

[1] Market Research Future, “Global G-CSF Market Analysis,” 2022.
[2] The Lancet Oncology, “A randomized trial of Tbo-filgrastim in chemotherapy-induced neutropenia,” 2022.
[3] Sandoz, “Zarxio (filgrastim-sndz) official prescribing information,” 2023.
[4] Pharma Intelligence, “Biosimilars Market Outlook,” 2023.
[5] U.S. FDA, “Biologics Approval Pathway,” 2022.