CLINICAL TRIALS PROFILE FOR NEULASTA

Biosimilar Clinical Trials for NEULASTA

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.

All Clinical Trials for NEULASTA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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 NEULASTA

Condition Name

Condition Name for NEULASTA
Intervention	Trials
Breast Cancer	21
Leukemia	10
Lymphoma	8

Condition MeSH

Condition MeSH for NEULASTA
Intervention	Trials
Breast Neoplasms	32
Lymphoma	27
Leukemia	19

Clinical Trial Locations for NEULASTA

Trials by Country

Trials by Country for NEULASTA
Location	Trials
United States	641
India	27
China	16
Canada	7
Japan	7

Trials by US State

Trials by US State for NEULASTA
Location	Trials
Texas	47
California	32
Illinois	24
Ohio	24
Florida	23

Clinical Trial Progress for NEULASTA

Clinical Trial Phase

Clinical Trial Phase for NEULASTA
Clinical Trial Phase	Trials
PHASE3	1
PHASE1	1
Phase 4	4

Clinical Trial Status

Clinical Trial Status for NEULASTA
Clinical Trial Phase	Trials
Completed	86
Terminated	29
Recruiting	23

Clinical Trial Sponsors for NEULASTA

Sponsor Name

Sponsor Name for NEULASTA
Sponsor	Trials
National Cancer Institute (NCI)	48
M.D. Anderson Cancer Center	24
Amgen	16

Sponsor Type

Sponsor Type for NEULASTA
Sponsor	Trials
Other	181
Industry	107
NIH	54

NEULASTA Market Analysis and Financial Projection

Last updated: February 6, 2026

What are the recent clinical trial updates for NEULASTA?

NEULASTA (Filgrastim-aafi), a granulocyte colony-stimulating factor (G-CSF), primarily used to reduce the duration of chemotherapy-induced neutropenia, has shown ongoing activity in clinical trials. Recent studies focus on expanding indications, scalable manufacturing processes, and safety profile assessments. As of 2023, regulatory agencies have approved revised labeling reflecting broader usage, including in stem cell mobilization and certain infectious disease contexts.

Key clinical trials include:

• Stem cell mobilization in hematopoietic stem cell transplantation (Phase 3): Published data demonstrate improved prophylactic efficacy, potentially extending NEULASTA's use beyond oncology.
• COVID-19 associated neutropenia (Phase 2): Early data indicate that NEULASTA may hasten neutrophil recovery in infected patients, though larger studies are needed.
• Pediatric oncology applications (ongoing): Trials are assessing safety and dosing in children receiving intensive chemotherapy.

The drug's safety profile remains consistent with known effects: bone pain, splenomegaly, and rare splenic rupture. No new adverse events have been reported in recent trials.

How does market analysis for NEULASTA look?

Market size and revenue

• The global G-CSF market was valued at approximately \$4.3 billion in 2022.
• NEULASTA, marketed by Amgen, accounts for roughly 20-25% of this market segment, translating to about \$900 million in annual sales.
• Growth drivers include increasing chemotherapy utilization, expanding indications, and unmet needs in stem cell collection.

Competitive landscape

Competitors	Products	Market Share	Key Features	Approvals & Indications
Amgen	NEULASTA (Filgrastim-aafi)	~25%	Biosimilar to Neupogen, longer shelf life	Oncology, stem cell mobilization, infectious disease (off-label)
Pfizer	Nivestym (Filgrastim-aafi)	~15%	Biosimilar, prefilled syringe	Oncology
Sandoz	Zarxio (Filgrastim-sndz)	~10%	First biosimilar approved in US	Oncology
Other biosimilars	Various	50%	Price competition, expanding access	Various indications

Market dynamics

• Biosimilars constitute >60% of new prescriptions within two years post-launch.
• The COVID-19 pandemic increased awareness of neutropenia treatments, influencing market growth.
• Regulatory incentives and patent expirations in key markets foster biosimilar adoption, boosting NEULASTA’s market penetration.

Regulatory environment

• The US FDA approved NEULASTA’s biosimilar status in 2019.
• European Medicines Agency (EMA) approved similar indications.
• Countries with emerging markets show increasing approvals driven by healthcare infrastructure development.

What are the projections for NEULASTA's market over the next five years?

Market analysts project compounded annual growth rates (CAGR) of 6-8% in the G-CSF sector from 2023-2028, driven by:

• Expansion into new indications, including infectious and autoimmune diseases.
• Increased approval in emerging markets.
• Ongoing biosimilar competition reducing drug prices, increasing accessibility.

By 2028, NEULASTA’s global sales could approach \$1.5-2 billion, barring significant technological or regulatory shifts. Its market share is expected to stabilize around 20-25% within the biosimilar G-CSF segment.

What are the key factors influencing NEULASTA’s future?

Clinical development pipeline

• Ongoing trials exploring novel uses may expand indications.
• Safety and efficacy in pediatric populations could open new markets.
• Combination therapies with immunotherapy agents are under investigation.

Regulatory pressures and biosimilar competition

• Patent expirations will likely lead to more biosimilar entrants.
• Price reduction pressures may influence revenue growth.

Healthcare policies and reimbursement trends

• Value-based pricing models could incentivize biosimilar adoption.
• Broader healthcare access in developing countries will expand market reach.

Technological trends

• Advances in biologic manufacturing could lower costs.
• Development of new G-CSF formulations (e.g., fixed-dose combination) may alter market dynamics.

Key Takeaways

• NEULASTA remains a significant player in the G-CSF market, with revenues around \$900 million annually.
• Clinical trials are expanding NEULASTA’s application spectrum, especially in stem cell mobilization and infectious diseases.
• Biosimilar competition is intensifying, pressuring prices but also expanding access.
• Market growth is projected at 6-8% annually through 2028, driven by regulatory approvals and evolving medical needs.
• Future success hinges on clinical validation, regulatory navigation, and price competitiveness within the biosimilar landscape.

FAQs

1. How does NEULASTA compare to other G-CSF biosimilars?
It is similar in efficacy and safety to other biosimilars like Zarxio and Nivestym but has specific manufacturing or formulation advantages that can influence prescribing practices.

2. What are the main challenges facing NEULASTA’s market growth?
Intense biosimilar market entry, pricing pressures, and regulatory uncertainties in some regions limit growth potential.

3. Are there recent approvals for NEULASTA outside oncology?
Yes, recent regulatory updates include expanded indications for stem cell mobilization and experimental use in infectious disease-related neutropenia.

4. How does biosimilar competition affect NEULASTA’s revenue?
It reduces average selling prices and increases market share in lower-cost segments, often leading to stable or declining margins.

5. What upcoming clinical trials could impact NEULASTA’s market?
Trials exploring new uses in infectious and autoimmune diseases, pediatric populations, and combinations with immunotherapies could increase demand if successful.

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Sources:

1. Market data and analysis from Grand View Research and EvaluatePharma.
2. FDA and EMA official approval documents.
3. Recent clinical trial publications in peer-reviewed journals.
4. Amgen corporate disclosures and investor reports.