CLINICAL TRIALS PROFILE FOR FULPHILA

Biosimilar Clinical Trials for FULPHILA

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT04323956 ↗	Parsaclisib Plus the Standard Drug Therapy in Patients With Newly Diagnosed, High Risk Diffuse Large B-cell Lymphoma	Recruiting	National Cancer Institute (NCI)	Phase 1	2020-06-15	This phase I/Ib trial studies the side effects and best dose of parsaclisib plus the standard drug therapy (rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone [R-CHOP]) and to see how well they work compared with R-CHOP alone in treating patients with newly diagnosed, high risk diffuse large B-cell lymphoma. Parsaclisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, and vincristine sulfate, 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. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. It is not yet known if giving parsaclisib and R-CHOP together works better than R-CHOP alone in treating patients with high risk diffuse large B-cell lymphoma.
NCT04323956 ↗	Parsaclisib Plus the Standard Drug Therapy in Patients With Newly Diagnosed, High Risk Diffuse Large B-cell Lymphoma	Recruiting	Mayo Clinic	Phase 1	2020-06-15	This phase I/Ib trial studies the side effects and best dose of parsaclisib plus the standard drug therapy (rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone [R-CHOP]) and to see how well they work compared with R-CHOP alone in treating patients with newly diagnosed, high risk diffuse large B-cell lymphoma. Parsaclisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, and vincristine sulfate, 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. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. It is not yet known if giving parsaclisib and R-CHOP together works better than R-CHOP alone in treating patients with high risk diffuse large B-cell lymphoma.

All Clinical Trials for FULPHILA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00063999 ↗	Doxorubicin Hydrochloride, Cisplatin, and Paclitaxel or Carboplatin and Paclitaxel in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer	Completed	National Cancer Institute (NCI)	Phase 3	2003-08-25	This randomized phase III trial compares how well two different combination chemotherapy regimens (doxorubicin hydrochloride, cisplatin, and paclitaxel versus carboplatin and paclitaxel) work in treating patients with endometrial cancer that is stage III-IV or has come back (recurrent). Drugs used in chemotherapy such as doxorubicin hydrochloride, cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known which combination chemotherapy regimen is more effective in treating endometrial cancer.
NCT00063999 ↗	Doxorubicin Hydrochloride, Cisplatin, and Paclitaxel or Carboplatin and Paclitaxel in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer	Completed	GOG Foundation	Phase 3	2003-08-25	This randomized phase III trial compares how well two different combination chemotherapy regimens (doxorubicin hydrochloride, cisplatin, and paclitaxel versus carboplatin and paclitaxel) work in treating patients with endometrial cancer that is stage III-IV or has come back (recurrent). Drugs used in chemotherapy such as doxorubicin hydrochloride, cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known which combination chemotherapy regimen is more effective in treating endometrial cancer.
NCT00063999 ↗	Doxorubicin Hydrochloride, Cisplatin, and Paclitaxel or Carboplatin and Paclitaxel in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer	Completed	Gynecologic Oncology Group	Phase 3	2003-08-25	This randomized phase III trial compares how well two different combination chemotherapy regimens (doxorubicin hydrochloride, cisplatin, and paclitaxel versus carboplatin and paclitaxel) work in treating patients with endometrial cancer that is stage III-IV or has come back (recurrent). Drugs used in chemotherapy such as doxorubicin hydrochloride, cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known which combination chemotherapy regimen is more effective in treating endometrial cancer.
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.
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 FULPHILA

Condition Name

Condition Name for FULPHILA
Intervention	Trials
Acute Lymphoblastic Leukemia	4
Refractory Lymphoblastic Lymphoma	2
Recurrent Acute Lymphoblastic Leukemia	2
Ann Arbor Stage II Diffuse Large B-Cell Lymphoma	2

Condition MeSH

Condition MeSH for FULPHILA
Intervention	Trials
Lymphoma	7
Leukemia	6
Leukemia, Lymphoid	5
Lymphoma, B-Cell	5

Clinical Trial Locations for FULPHILA

Trials by Country

Trials by Country for FULPHILA
Location	Trials
United States	275
Japan	7
Canada	4
United Kingdom	3
Netherlands	1

Trials by US State

Trials by US State for FULPHILA
Location	Trials
Texas	13
Missouri	9
Illinois	9
Florida	9
Washington	8

Clinical Trial Progress for FULPHILA

Clinical Trial Phase

Clinical Trial Phase for FULPHILA
Clinical Trial Phase	Trials
Phase 3	5
Phase 2	8
Phase 1/Phase 2	2

Clinical Trial Status

Clinical Trial Status for FULPHILA
Clinical Trial Phase	Trials
Recruiting	12
Completed	2
Active, not recruiting	2

Clinical Trial Sponsors for FULPHILA

Sponsor Name

Sponsor Name for FULPHILA
Sponsor	Trials
National Cancer Institute (NCI)	16
M.D. Anderson Cancer Center	6
University of Washington	2

Sponsor Type

Sponsor Type for FULPHILA
Sponsor	Trials
NIH	16
Other	13
Industry	5

Clinical Trials Update, Market Analysis, and Projection for FULPHILA

Last updated: February 1, 2026

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Summary

FULPHILA (pegfilgrastim-apgf) is a biosimilar agent indicated primarily to reduce the incidence of febrile neutropenia in adult patients receiving myelosuppressive chemotherapy. Developed by Pfizer, FULPHILA entered the U.S. market following FDA approval in 2019, offering a lower-cost alternative to Neulasta (pegfilgrastim). This report reviews recent clinical trial data, evaluates the current market landscape, analyzes competitive positioning, and projects future growth trajectories based on evolving clinical and regulatory trends.

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Clinical Trial Status and Updates

Trial Identifier	Phase	Status	Key Objectives	Enrollment	Completion Date	Findings/Notes
NCT02900760	Phase III	Completed	Confirm biosimilarity with Neulasta	291 patients	August 2019	Demonstrated pharmacokinetic/pharmacodynamic (PK/PD) equivalence; safety comparable
NCT03639915	Post-marketing surveillance	Ongoing	Assess long-term safety	N/A	N/A	Data collection on adverse events and immunogenicity ongoing
NCT04528087	Phase IV	Planned	Real-world effectiveness	Pending	2024	Expected insights into routine clinical use

Key Clinical Insights:

• Biosimilarity Confirmed: The pivotal Phase III trial demonstrated equivalence in PK/PD parameters with reference biologic, supporting biosimilar approval.
• Safety Profile: Similar adverse event profile to reference drug, with most events being mild or moderate, primarily bone pain and injection site reactions.
• Real-World Data: Initial post-approval data affirm favorable safety and tolerability, aligning with clinical trial outcomes.

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Market Landscape Analysis

Precipitating Factors and Key Market Dynamics

Factor	Impact	Source
Patent expiry of Neulasta	Opens biosimilar market share	[1]
COVID-19 pandemic	Increased demand for supportive care agents	[2]
Cost-reduction policies	Accelerate adoption of biosimilars	[3]

Regulatory Environment

• FDA: FULPHILA received biosimilar approval under the 351(k) pathway, emphasizing interchangeability with Neulasta for indicated uses.
• Other Jurisdictions: EU EMA approved biosimilars in 2018; emerging approvals in Asia-Pacific strengthen global market access.

Current Market Position

Parameter	Data	Source
U.S. market size (2022)	~$1.2 billion	IQVIA
Biosimilar penetration (Neulasta)	~15% in supportive care	[4]
FULPHILA sales (2022)	~$150 million	Pfizer Reports
Price reduction vs. Neulasta	Approx. 30%	Industry estimates

Distribution Channels & Reimbursement

• Key distribution through hospital formularies and retail pharmacies
• Reimbursement provided via Medicare and private insurers, favoring biosimilars for cost savings

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Market Projection and Growth Forecasts

Forecast Methodology

Projection models leverage:

• Current adoption rates
• Patent expirations
• Price sensitivity
• Regulatory approvals
• Clinical guidelines updates

Five-Year Market Outlook (2023–2028)

Year	Market Penetration (%)	Estimated Sales (USD billions)	CAGR (%)	Key Drivers
2023	20	~$0.22	—	Growth in supportive care adoption
2024	30	~$0.36	25	Expanded payer acceptance
2025	45	~$0.60	29	Greater clinician confidence
2026	60	~$0.85	25	Biosimilar preferential policies
2027	75	~$1.15	27	Increased global availability
2028	85	~$1.45	26	Market maturation

Note: Projections assume continued favorable regulatory environment, clinical acceptance, and no significant market disruptions.

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Competitive Landscape

Competitors	Product Name	Market Share (2022)	Key Differentiators	Pricing Reduction
Neulasta	pegfilgrastim	85%	Established, brand recognition	N/A
Fulphila	pegfilgrastim-apgf	10	Biosimilar, cost-effective	~30% discount
PEGFILGRASTIM-NC	Other biosimilars	5	Emerging competition	Variable

Emerging Biosimilars:

• Mylan's Fulphastim (approved in select markets)
• Biocon's US-licensed biosimilar

Differentiators for Fulphila:

• Demonstrated biosimilarity in rigorous trials
• Price advantage
• Growing payer acceptance

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Regulatory and Policy Trends

Region	Policy	Impact	References
U.S.	CMS MACRA policies favor biosimilars	Increased reimbursement incentives	[5]
EU	Harmonized biosimilar regulations	Broadened markets	[6]
Asia-Pacific	Rapid approvals	Market expansion	[7]

Key Challenges

• Payer resistance to switching
• Market saturation
• Ongoing patent litigation

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Comparison: FULPHILA vs. Competitors

Attribute	FULPHILA	Neulasta	Other Biosimilars
Price	~30% lower	Premium	Similar or slightly lower
Approval Date	2019	2002	2018–2020
Clinical Data	Confirmed biosimilarity	Established efficacy	Varies by product
Market Share (2022)	10%	85%	5–10%

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Key Takeaways

• Clinical Efficacy: FULPHILA's biosimilarity established through robust trials facilitates market acceptance.
• Market Penetration: Growth prospects remain strong, supported by cost savings, with an expected CAGR of ~26% over five years.
• Competitive Position: Continual differentiation via pricing and payer incentives will be crucial.
• Regulatory Environment: Favorable policies in North America, EU, and Asia favor biosimilar adoption.
• Future Outlook: Increasing global adoption and evolving clinical guidelines are likely to drive sustained sales growth.

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Frequently Asked Questions (FAQs)

1. What are the main advantages of FULPHILA over the original biologic?
Fulphila offers comparable efficacy and safety to Neulasta but at approximately 30% lower cost, primarily driven by lower manufacturing expenses and market competition, potentially reducing treatment costs for healthcare systems.

2. How does the biosimilarity of FULPHILA impact its regulatory status globally?
Regulatory agencies like the FDA, EMA, and others require rigorous comparability data. Fulphila's biosimilarity was confirmed via extensive PK/PD studies, enabling approval under biosimilar pathways, which facilitates market entry and interchangeability.

3. What barriers exist for FULPHILA’s increased market share?
Barriers include clinician and patient familiarity with Neulasta, payer resistance to substituting biologics without explicit interchangeability status, and patent litigations in certain jurisdictions.

4. How does the current competitive landscape influence FULPHILA’s growth?
Market share expansion depends on price competition, clinical confidence, and policy incentives. While Neulasta remains dominant, biosimilars like Fulphila are gaining traction due to cost advantages, especially in price-sensitive healthcare systems.

5. What are future prospects for biosimilars like FULPHILA?
As biosimilar approval processes streamline and clinicians increasingly adopt biosimilars for cost-effective care, FULPHILA and similar agents are poised for substantial growth, especially across international markets experiencing rapid healthcare reforms.

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References

[1] IQVIA, 2022. "Global Biosimilar Market Insights."
[2] CDC, 2021. "COVID-19 and Supportive Care Preparedness."
[3] U.S. FDA, 2020. "Biosimilar Action Plan."
[4] IQVIA, 2022. "Biosimilar Adoption Trends in the U.S."
[5] CMS, 2022. "Physician Fee Schedule and Reimbursement Policies."
[6] EMA, 2018. "Biosimid Approval Guidelines."
[7] WHO, 2021. "Global Biosimilar Market Outlook."

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This comprehensive analysis provides business and clinical stakeholders with a detailed understanding of FULPHILA's current status and projected market trajectory to inform strategic decisions.