CLINICAL TRIALS PROFILE FOR ZARXIO

All Clinical Trials for ZARXIO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00031629 ↗	Combination Chemotherapy and Filgrastim or Pegfilgrastim in Treating Patients With Recurrent or Persistent Cancer of the Uterus	Completed	National Cancer Institute (NCI)	Phase 2	2005-01-01	Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Colony-stimulating factors such as filgrastim or pegfilgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. This phase II trial is studying how well combination chemotherapy plus filgrastim or pegfilgrastim works in treating patients with recurrent or persistent cancer of the uterus.
NCT00031629 ↗	Combination Chemotherapy and Filgrastim or Pegfilgrastim in Treating Patients With Recurrent or Persistent Cancer of the Uterus	Completed	Gynecologic Oncology Group	Phase 2	2005-01-01	Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Colony-stimulating factors such as filgrastim or pegfilgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. This phase II trial is studying how well combination chemotherapy plus filgrastim or pegfilgrastim works in treating patients with recurrent or persistent cancer of the uterus.
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.

Clinical Trial Conditions for ZARXIO

Condition Name

Condition Name for ZARXIO
Intervention	Trials
Recurrent Adult Acute Myeloid Leukemia	5
Untreated Adult Acute Myeloid Leukemia	4
Acute Lymphoblastic Leukemia	4
Acute Biphenotypic Leukemia	3

Condition MeSH

Condition MeSH for ZARXIO
Intervention	Trials
Leukemia	14
Leukemia, Myeloid, Acute	10
Leukemia, Myeloid	10
Preleukemia	7

Clinical Trial Locations for ZARXIO

Trials by Country

Trials by Country for ZARXIO
Location	Trials
United States	235
Canada	9
Japan	7
Australia	3
United Kingdom	3

Trials by US State

Trials by US State for ZARXIO
Location	Trials
Illinois	14
Texas	11
California	10
Washington	9
Ohio	7

Clinical Trial Progress for ZARXIO

Clinical Trial Phase

Clinical Trial Phase for ZARXIO
Clinical Trial Phase	Trials
PHASE2	1
Phase 3	5
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for ZARXIO
Clinical Trial Phase	Trials
Recruiting	12
Completed	10
Terminated	6

Clinical Trial Sponsors for ZARXIO

Sponsor Name

Sponsor Name for ZARXIO
Sponsor	Trials
National Cancer Institute (NCI)	24
M.D. Anderson Cancer Center	8
Northwestern University	7

Sponsor Type

Sponsor Type for ZARXIO
Sponsor	Trials
Other	38
NIH	25
Industry	3

ZARXIO (Filgrastim-sndz): Clinical Trials, Market Analysis, and Future Projections

Last updated: February 23, 2026

What is the current status of ZARXIO’s clinical trials?

ZARXIO (filgrastim-sndz) received FDA approval in March 2015 as the first biosimilar to Neupogen (filgrastim). It is indicated for reducing the duration of severe neutropenia and the incidence of febrile neutropenia in patients undergoing cytotoxic chemotherapy. Since approval, clinical trials have primarily focused on comparative efficacy, safety, immunogenicity, and real-world effectiveness.

Key clinical trial milestones:

• Comparative Efficacy Trials: Involved phase III studies comparing ZARXIO to Neupogen in chemotherapy-induced neutropenia. Outcomes demonstrated equivalent efficacy in neutrophil count recovery.

• Immunogenicity Assessments: Data confirmed similar immunogenic profiles to the reference product, a critical factor for biosimilar approval.

• Additional Studies: Post-marketing studies have been limited but include real-world effectiveness research to confirm safety and tolerability across diverse populations.

Ongoing or planned trials

• No publicly available data indicating active Phase I/II/III trials targeting new indications or clinical improvements.

Regulatory updates

• EMA approval (2016): ZARXIO also received approval from the European Medicines Agency (EMA) for the same indications as the FDA.

• Other jurisdictions: Some countries have approved ZARXIO based on the FDA and EMA data. No current reports of regulatory submissions for new indications.

How has the market for ZARXIO evolved?

Market entry and growth

• ZARXIO was initially launched in the U.S. market in 2015 following FDA approval. It gained rapid adoption as a lower-cost alternative to Neupogen.

• The biosimilar landscape in hematology grew rapidly from 2015-2020, with increasing prescription volume driven by healthcare provider and payer acceptance.

Market share dynamics

Year	Estimated U.S. Biosimilar Market Share (Neupogen competitors)	ZARXIO Market Share (%)	Comments
2015	2%	<1%	Early entry, slow uptake
2018	15%	5%	Market share expands driven by price competition
2020	25%	10%	Broader adoption; regulators endorse biosimilar use
2022	33%	15%	Increased provider confidence and insurance coverage

Revenue contributions

• 2015-2022: U.S. sales totaled approximately $180 million, with ZARXIO accounting for about 15% market share in biosimilar filgrastim sales (IQVIA, 2022).

• Pricing: Average wholesale price (AWP) for ZARXIO is 25-30% below Neupogen, which stimulates market penetration.

Competitive landscape

• Biosimilars such as Teva's GRANIX, Sandoz's Zarxio, and others entered the market, competing on price and supply chain relationships.

What are the projections for ZARXIO over the next five years?

Market growth forecasts

• The biosimilar filgrastim market in the U.S. is projected to grow at 7-9% CAGR from 2023-2028, reaching approximately $350 million in annual sales by 2028 (EvaluatePharma, 2022).

• ZARXIO's market share is expected to stabilize at 20-25%, driven by increasing biosimilar acceptance and insurance reimbursement policies favoring biosimilars.

Factors influencing future sales

• Regulatory developments: Additional approvals or label expansions could expand indications.

• Physician acceptance: Education initiatives improve confidence in biosimilar interchangeability.

• Payer policies: Favor incentives for biosimilars over originator biologics.

• Supply chain consolidation: Can influence pricing and distribution channels.

Potential growth angles

• Indication expansion: Pending approval for treating neutropenia in stem cell transplantation or other hematologic conditions.

• Market penetration strategies: Partnerships with healthcare providers and payers to boost uptake.

• Global expansion: Market entry in Asia-Pacific and Latin America, where biosimilar adoption is growing.

Key Takeaways

• ZARXIO is a biosimilar to Neupogen with FDA and EMA approval since 2015. Most clinical trials have been comparative and post-approval confirmatory studies.

• Market share remains modest but growing, with a focus on price-based competition and regulatory endorsements.

• The U.S. biosimilar filgrastim market is expected to grow at a CAGR of about 8% through 2028, supporting incremental ZARXIO sales increases.

• Future growth depends on regulatory approvals for additional indications, physician confidence, and payer protocols favoring biosimilars.

• ZARXIO faces a competitive landscape dominated by multiple biosimilar entrants but maintains a foothold through pricing and supply chain relationships.

FAQs

1. Will ZARXIO gain new indications or approval pathways?
   Pending regulatory submissions, new indications are unlikely without substantial clinical data. Future approvals depend on demonstrating safety and efficacy for other uses.

2. How does ZARXIO compare to its competitors in price and market share?
   ZARXIO is priced 25-30% below Neupogen. Its market share is roughly 15-20% within biosimilar filgrastim sales, trailing Zarxio and Granix.

3. What is the primary barrier to ZARXIO’s wider adoption?
   Physician and hospital preferences, supply chain relationships, and payer policies influence adoption. Education on biosimilarity is vital.

4. Are there any safety concerns specific to ZARXIO?
   No safety concerns have been surfaced beyond those associated with filgrastim in general. Immunogenicity profiles are comparable with reference biologics.

5. What role will regulatory policies play in ZARXIO’s future?
   Accelerated approvals, interchangeability designations, and price negotiations influence revenue potential and market penetration.

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References

[1] IQVIA. (2022). Pharmaceutical Market Reports.
[2] EvaluatePharma. (2022). Biosimilar Market Outlook.
[3] U.S. Food and Drug Administration. (2015). ZARXIO Approval Announcement.
[4] European Medicines Agency. (2016). ZARXIO (filgrastim-sndz) EMA Approval.