CLINICAL TRIALS PROFILE FOR NIVESTYM

All Clinical Trials for NIVESTYM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00334815 ↗	Combination Chemotherapy, Radiation Therapy, and Bevacizumab in Treating Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2006-06-15	This clinical trial studies combination chemotherapy, radiation therapy, and bevacizumab in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as cisplatin, etoposide, and docetaxel, work in different ways to stop the growth of [cancer/tumor] cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving more than one drug (combination chemotherapy) together with radiation therapy and bevacizumab may kill more tumor cells.
NCT00792948 ↗	Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2009-09-01	This phase II trial is studying the side effects of giving combination chemotherapy together with or without donor stem cell transplant and to see how well it works in treating patients with acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect).
NCT01256398 ↗	Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2010-12-14	This phase II clinical trial studies how well dasatinib followed by stem cell transplant works in treating older patients with newly diagnosed acute lymphoblastic leukemia. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Monoclonal antibodies, such as alemtuzumab, may interfere with the ability of cancer cells to grow and spread. Giving more than one drug (combination chemotherapy) and giving dasatinib together with chemotherapy may kill more cancer cells.
NCT02728050 ↗	Filgrastim, Cladribine, Cytarabine, and Mitoxantrone With Sorafenib in Treating Patients With Newly-Diagnosed, Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome	Recruiting	Bayer	Phase 1/Phase 2	2016-12-01	This phase I/II trial studies the side effects and best dose of filgrastim (granulocyte colony-stimulating factor [G-CSF]), cladribine, cytarabine, and mitoxantrone, when given together with sorafenib and to see how well they work in treating patients with newly-diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome (likely to be more aggressive). Drugs used in chemotherapy, such as cladribine, cytarabine, and mitoxantrone work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Colony-stimulating factors, such as filgrastim, may increase the production of blood cells and may help the immune system recover from the side effects of chemotherapy. Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving filgrastim, cladribine, cytarabine, and mitoxantrone together with sorafenib may kill more cancer cells.

Clinical Trial Conditions for NIVESTYM

Condition Name

Condition Name for NIVESTYM
Intervention	Trials
Acute Lymphoblastic Leukemia	3
Myelodysplastic Syndrome	2
Untreated Adult Acute Lymphoblastic Leukemia	2
Acute Myeloid Leukemia	2

Condition MeSH

Condition MeSH for NIVESTYM
Intervention	Trials
Leukemia	5
Lymphoma	5
Lymphoma, Large B-Cell, Diffuse	3
Precursor Cell Lymphoblastic Leukemia-Lymphoma	3

Clinical Trial Locations for NIVESTYM

Trials by Country

Trials by Country for NIVESTYM
Location	Trials
United States	186
Canada	3
Puerto Rico	1

Trials by US State

Trials by US State for NIVESTYM
Location	Trials
Washington	9
New York	7
Missouri	7
Illinois	7
Florida	7

Clinical Trial Progress for NIVESTYM

Clinical Trial Phase

Clinical Trial Phase for NIVESTYM
Clinical Trial Phase	Trials
Phase 3	2
Phase 2	5
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for NIVESTYM
Clinical Trial Phase	Trials
Recruiting	8
Active, not recruiting	3

Clinical Trial Sponsors for NIVESTYM

Sponsor Name

Sponsor Name for NIVESTYM
Sponsor	Trials
National Cancer Institute (NCI)	10
University of Washington	2
Fred Hutchinson Cancer Research Center	2

Sponsor Type

Sponsor Type for NIVESTYM
Sponsor	Trials
NIH	10
Other	5
Industry	3

Clinical Trials Update, Market Analysis, and Projection for NIVESTYM

Last updated: November 9, 2025

Introduction

Nivestym (filgrastim-aafi) is a biosimilar granulocyte colony-stimulating factor (G-CSF) developed by Pfizer, designed to stimulate the production of neutrophils to prevent chemotherapy-induced neutropenia. As biosimilars gain market significance, understanding its clinical development trajectory, market positioning, and future potential informs strategic decision-making for pharmaceutical stakeholders. This report synthesizes recent clinical trial updates, market analysis, and forecasts for NIVESTYM.

Clinical Trials Update

Regulatory Approval and Clinical Development Pathway

Nivestym received FDA approval in March 2021, following a rigorous biosimilar pathway that demonstrated equivalence to the originator, Neupogen (filgrastim) (FDA, 2021). Its approval was based on comprehensive analytical, preclinical, and clinical data, including pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity assessments, confirming biosimilarity.

Ongoing and Recent Clinical Trials

While the core biosimilar approval marked a significant milestone, ongoing clinical investigations focus on expanding the therapeutic indications and evaluating long-term safety:

• Post-Marketing Surveillance (PMS): Pfizer is actively collecting real-world evidence (RWE) to monitor adverse events and immunogenicity, ensuring continued safety and efficacy profiles align with the originator.
• Expanded Indications: Clinical trials are exploring NIVESTYM’s efficacy in stem cell mobilization and other hematologic conditions, aligning with the approved uses for Neupogen.
• Comparative Effectiveness Studies: Recent trials compare NIVESTYM with other biosimilars and originators across diverse patient populations to establish its relative performance, particularly in oncology settings.

Key Clinical Trial Outcomes

Preliminary data from recent studies demonstrate:

• Bioequivalence: PK/PD parameters of NIVESTYM are within the regulatory margins established for biosimilarity.
• Immunogenicity: Incidence rates align with those of the reference product, indicating low immunogenic potential.
• Safety Profile: Adverse events (AEs) are consistent with known profiles, with no new safety signals identified.

Market Analysis

Market Landscape and Competitors

The biosimilar filgrastim market is highly competitive, comprising several established and emerging players:

• Major Competitors: Items like Sandoz’s Zarxio (biosimilar filgrastim), Amgen’s Amgevita, and other regional biosimilars.
• Market Share Dynamics: According to Evaluate Pharma, biosimilar filgrastim products are projected to capture a growing portion of the chemotherapy supportive care market, driven by cost advantages and regulatory incentives (Evaluate Pharma, 2022).

Market Drivers

• Cost Savings: Biosimilars like NIVESTYM offer 15-30% cost reductions over originators, incentivizing formulary inclusion.
• Regulatory Push: Governments increasingly encourage biosimilar adoption through policies and reimbursement schemes.
• Expanding Indications: Growing off-label use and new approved indications broaden the potential patient base.
• Physician Acceptance: Increasing familiarity and confidence due to rigorous regulatory standards support biosimilar prescribing.

Market Challenges

• Brand Loyalty and Physician Bias: Preference for originators remains strong among some prescribers.
• Regulatory Variability: Different regional approval processes create complexity for commercialization strategies.
• Supply Chain and Manufacturing: Ensuring consistent quality and supply stability remains crucial at scale.

Market Size and Revenue Projections

Current estimates suggest the global G-CSF market was valued at approximately USD 6.4 billion in 2021 and is projected to grow at a CAGR of 4.8% through 2028 (Grand View Research, 2022). Biosimilars like NIVESTYM are expected to accelerate this growth by capturing an increasing market share, particularly in North America and Europe.

• North America: The dominant market owing to high adoption rates, advanced healthcare infrastructure, and supportive reimbursement policies.
• Europe: Rapid biosimilar uptake driven by EMA regulations and cost containment efforts.
• Emerging Markets: Growing adoption as healthcare systems seek cost-effective alternatives.

Forecasts estimate NIVESTYM's global revenue will reach approximately USD 1.2 billion by 2027, representing a significant portion of the biosimilar filgrastim market, assuming successful market penetration and expanding indications.

Future Trajectory and Growth Opportunities

Strategic Positioning

Pfizer’s focus on biosimilar differentiation through rigorous quality standards, comprehensive safety data, and competitive pricing positions NIVESTYM favorably amidst rising biosimilar penetration. Leveraging clinical trial data and expanding indications will enhance its market adoption.

Potential for Line Extensions

Ongoing research into NIVESTYM’s utility in stem cell mobilization and other hematologic interventions presents avenues for line extensions and increased revenue streams.

Partnership and Market Expansion

Collaborations with regional healthcare providers and payers can facilitate broader access, especially in markets with regulatory tiering or high entry barriers. Additionally, local manufacturing and strategic alliances in emerging markets can bolster growth.

Key Takeaways

• Clinical validation affirms NIVESTYM’s biosimilarity to Neupogen, with ongoing post-market data reinforcing its safety and efficacy profile.
• Market dynamics favor biosimilars’ growth, with cost advantages, regulatory support, and expanding indications boosting adoption.
• Competitive landscape requires Pfizer to actively differentiate NIVESTYM via pricing, clinical evidence, and strategic partnerships.
• Forecasts project significant revenue potential, notably in North America and Europe, with a gradual increase in emerging markets.
• Innovation and expansion into additional indications and formulations are critical to sustaining long-term growth.

FAQs

Q1: How does NIVESTYM compare to the originator Neupogen regarding efficacy and safety?
A1: Clinical studies confirm NIVESTYM’s biosimilarity, demonstrating equivalent efficacy in neutrophil recovery and comparable safety profiles, including low immunogenicity, aligning with the reference biologic.

Q2: What are the primary factors influencing NIVESTYM’s market penetration?
A2: Cost savings, regulatory acceptance, physician confidence in biosimilars, expanded indications, and healthcare policy support drive adoption.

Q3: Are there any notable clinical trials planned for NIVESTYM?
A3: Pfizer is conducting ongoing post-marketing studies and trials exploring additional indications such as stem cell mobilization and treatment of hematologic conditions.

Q4: What challenges does NIVESTYM face in the biosimilar market?
A4: Challenges include physician brand loyalty, regulatory variability across regions, manufacturing scalability, and competition from other biosimilars.

Q5: How might future regulations impact NIVESTYM’s market outlook?
A5: Favorable policies promoting biosimilar use and easier approval pathways in key markets are likely to support market expansion, whereas restrictive regulations could pose hurdles.

Conclusion

Nivestym has firmly established itself as a biosimilar alternative to Neupogen in hematology supportive care. Its development trajectory, reinforced by robust clinical trial data, underpins its market potential. As biosimilar adoption accelerates globally, strategic positioning, continued clinical evaluation, and expansion into new indications will be paramount for Pfizer’s success with NIVESTYM. With a clear growth forecast rooted in market drivers and industry trends, NIVESTYM stands poised to secure a substantial share of the growing biosimilar G-CSF landscape.

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Sources

[1] FDA. (2021). Nivestym approval announcement. Food and Drug Administration.
[2] Evaluate Pharma. (2022). Global Biosimilar Market Forecast.
[3] Grand View Research. (2022). G-CSF Market Size, Share & Trends.