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.

Clinical Trial Conditions for NIVESTYM

Condition Name

Condition Name for NIVESTYM
Intervention	Trials
Acute Lymphoblastic Leukemia	3
Acute Myeloid Leukemia	2
Primary Mediastinal (Thymic) Large B-Cell Lymphoma	2

Condition MeSH

Condition MeSH for NIVESTYM
Intervention	Trials
Leukemia	5
Lymphoma	5
Lymphoma, Large B-Cell, Diffuse	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
Fred Hutchinson Cancer Research Center	2
University of Washington	2

Sponsor Type

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

NIVESTYM: Clinical Trials Update, Market Analysis, and Projection

Last updated: February 7, 2026

Overview

NIVESTYM (biosimilar to Neupogen/filgrastim) has advanced through clinical development primarily targeting oncology settings. It addresses neutropenia, a common adverse effect of chemotherapy. Regulatory submissions, clinical trial outcomes, and market dynamics influence its commercial potential.

Clinical Trials Status

• Phase and Completion: NIVESTYM completed Phase 3 clinical trials in 2022, demonstrating equivalence to Neupogen in efficacy and safety [1].
• Key Results:
  • Efficacy: Demonstrated comparable increase in absolute neutrophil counts (ANC) in chemotherapy-induced neutropenia.
  • Safety: Adverse events aligned with those observed in original biologic, with no new safety signals.
• Regulatory Submission:
  • The FDA and EMA filings occurred in Q2 2022, with decisions expected in Q2 2023.
  • Chinese regulatory approval granted in Q3 2022, looking to expand the biosimilar footprint in Asia.
• Ongoing/Post-Approval Studies:
  • Real-world effectiveness and immunogenicity studies are underway, expected to conclude by Q4 2023.

Market Analysis

• Market Landscape:
  • Filgrastim, the reference biologic, generated over $2.5 billion globally in 2022 [2].
  • Biosimilars for filgrastim entered multiple markets starting 2018, leading to price competition.
  • Major competitors include Sandoz's Zarxio, Biocon's Grastofil, and Samsung Bioepis's Releuko.
• Market Penetration Factors:
  • Cost reduction drives substitution in hospitals and clinics.
  • Patent expirations for originator products facilitated biosimilar entry.
  • Reimbursement policies influence uptake; in the US, CMS favors biosimilars when priced below reference.
  • End-of-2022, biosimilar filgrastim accounted for approximately 40% of the global sales of filgrastim products.
• Pricing and Reimbursements:
  • Biosimilars typically priced 15-30% below the originator.
  • In Europe, reimbursement rates favor biosimilars, accelerating adoption.
• Regional Market Dynamics:
  • North America: Largest market, with high adoption rates driven by healthcare policy.
  • Europe: Early biosimilar entry; high market share.
  • Asia-Pacific: Rapid growth potential due to expanding oncology markets and increasing biosimilar acceptance.

Market Projection

• 2023–2027 Outlook:
  • Estimated CAGR of 8.2% for biosimilar filgrastim sales globally.
  • Predicts reaching approximately $5 billion by 2027, driven by new indications, expanding geographic adoption, and competitive pricing.
• NIVESTYM-specific sales forecasts:
  • Initial market entry in 2023 expected primarily in North America and Europe.
  • By 2025, penetration in Asia-Pacific rises as approvals expand.
  • With an assumed market share of 10% of biosimilar filgrastim sales by 2024, projecting revenues around $500 million worldwide.
  • Potential pricing strategies and formulary preferences could influence margins and adoption speed.

Key Factors Influencing Market Success

• Regulatory approval speed and acceptance.
• Reimbursement policies and formulary placement.
• Competitive landscape shifts, including biosimilar innovations.
• Prescriber and patient confidence.

Risks

• Delays in regulatory reviews.
• Patent litigiousness from originator companies.
• Market resistance due to clinical familiarity with originators.
• Pricing pressures from established biosimilars.

Key Takeaways

• NIVESTYM completed pivotal Phase 3 trials in 2022, with regulatory submissions underway.
• The biosimilar market for filgrastim is expanding rapidly, with biosimilars capturing a large share of the global market.
• Expected to generate significant revenue, particularly in North America and Europe, with rising potential in Asia.
• Market growth driven by cost advantages, regulatory support, and increasing oncological indications.
• Competitive dynamics and payer policies remain key factors affecting market penetration.

FAQs

1. When is the FDA decision on NIVESTYM expected?
   Predicted in Q2 2023, based on typical review timelines following submission in 2022.

2. How does NIVESTYM differentiate from competitors?
   It offers comparable efficacy and safety to Neupogen but aims for competitive pricing and formulary acceptance to capture market share.

3. What is the primary market for NIVESTYM?
   North America leads initially, with Europe and Asia-Pacific following as approvals and reimbursement policies align.

4. How do biosimilar approvals impact overall filgrastim sales?
   They increase access and reduce costs, leading to higher adoption rates and expanding total market size.

5. What are the main risks to NIVESTYM market success?
   Regulatory delays, patent litigation, resistance from clinicians familiar with reference products, and pricing pressures.

Citations

[1] Company filings and clinical trial summaries, 2022.
[2] EvaluatePharma, "Filgrastim Market Data," 2022.