Zarxio (filgrastim-sndz)
/ Sandoz
- LARVOL DELTA
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February 24, 2025
A Case of Rare Pulmonary Manifestations in Multiple Myeloma
(ATS 2025)
- "The patient also noted he recently started Zarxio (Filgastrim-sndz) in anticipation of a bone marrow transplant...However, it is important for clinicians to also identify the extramedullary manifestations of MM as they can serve as strong prognostic indicators for disease severity and can help guide management. The case above adds to the growing body of evidence for the degree of disease severity associated with myelomatous pleural effusions and should therefore help prompt physicians to maintain a low threshold for pursuing invasive diagnostic measures in these patients when suspected."
Clinical • Anemia • Bone Marrow Transplantation • Diabetes • Endocrine Disorders • Hematological Disorders • Hematological Malignancies • Infectious Disease • Metabolic Disorders • Multiple Myeloma • Nephrology • Neutropenia • Oncology • Plasmacytoma • Pulmonary Disease • Renal Disease • Respiratory Diseases • Scleroderma
April 25, 2025
Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
(clinicaltrials.gov)
- P2 | N=270 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Dec 2026 ➔ Oct 2028 | Trial primary completion date: Dec 2026 ➔ Oct 2028
Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology
December 07, 2024
Patterns of Medicare Utilization and Spending on Granulocyte Colony-Stimulating Factors: Filgrastim, Pegfilgrastim, and Their Biosimilars
(ASH 2024)
- "Data for Neupogen and its biosimilars (Zarxio, Nivestym, Granix) and Neulasta and its biosimilars (Fulphila, Udenyca, Ziextenzo and Nyvepria) was extracted. Neulasta maintains the lowest average spending per beneficiary, highlighting its ongoing value proposition despite the increasing role of biosimilars in the treatment landscape. In conclusion, by leveraging the market competition from biosimilars, the healthcare system can achieve a more balanced approach to delivering high-quality care while managing costs effectively."
Medicare • Reimbursement • US reimbursement • Hematological Disorders
October 23, 2024
Real world comparison of filgrastim to filgrastim-sndz in patients with chemotherapy-induced neutropenia.
(PubMed, J Oncol Pharm Pract)
- "filgrastim-sndz significantly reduced healthcare utilization costs compared to reference filgrastim with similar effect on absolute neutrophil count, incidence of fever, and febrile neutropenia."
Journal • Real-world • Real-world evidence • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Oncology • Transplantation
August 01, 2024
A CASE OF REFRACTORY IMMUNE THROMBOCYTOPENIA IN THE SETTING OF ABDOMINAL SPLENOSIS
(CHEST 2024)
- "CASE PRESENTATION: A 25-year-old woman with known ITP (s/p prior splenectomy and previous admissions requiring IVIG and high dose Dexamethasone, and currently on daily Prednisone) presented with severe thrombocytopenia (platelet level of 4000/uL) during a routine hematology visit...Over the subsequent several weeks of hospital stay, the patient was trialed on IVIG, Prednisone, Mycophenolate Mofetil, Vincristine, and eventually, weekly Romiplostim and Rituximab...Since discharge, the patient is being treated with twice weekly platelet transfusions and Zarxio, and weekly romiplostim and Fostamatinib, with platelet numbers more recently starting to recover (currently 42000/uL). Here is a unique case of a patient with thrombocytopenia secondary to ITP that was refractory to all available treatments, including splenectomy, Rituximab and thrombopoietin receptor agonists.[7] Given prior case reports with recurrent ITP in the setting of abdominal splenosis, it is worthwhile to..."
Clinical • Cerebral Hemorrhage • CNS Disorders • Fatigue • Gynecology • Hematological Disorders • Immune Thrombocytopenic Purpura • Rare Diseases • Thrombocytopenia • Thrombocytopenic Purpura
September 20, 2024
Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
(clinicaltrials.gov)
- P2 | N=270 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Dec 2024 ➔ Dec 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2026
Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology
September 19, 2024
SMART: Non-interventional, Long-term Safety Data Collection of Zarzio® / Filgrastim HEXAL® in Stem Cell Donors
(clinicaltrials.gov)
- P=N/A | N=245 | Completed | Sponsor: Sandoz | Active, not recruiting ➔ Completed
Trial completion
July 26, 2024
Real-World Noninferiority Assessment of Two Filgrastim Biosimilars in Patients Receiving Myelosuppressive Chemotherapy.
(PubMed, JCO Oncol Pract)
- "Among patients with select solid tumors receiving myelosuppressive chemotherapy, severe neutropenia outcomes were comparable between filgrastim-aafi and filgrastim-sndz biosimilars. Findings from this study may support utilization of different filgrastim biosimilars in clinical practice."
Head-to-Head • Journal • Real-world • Real-world evidence • Breast Cancer • Febrile Neutropenia • Hematological Disorders • Neutropenia • Oncology • Solid Tumor
May 02, 2024
Cencora Analysis Shows Differences in Payer Coverage Between G-CSF Biosimilars
(Center for Biosimilars)
- "According to a study by Cencora, there is a discrepancy in payer coverage for granulocyte colony-stimulating factor (G-CSF) biosimilars. Although filgrastim biosimilars are frequently preferred over the originator (Neupogen), reference pegfilgrastim (Neulasta) continues to hold a dominant position over its biosimilar counterparts....From the analyzed payers, 38 (76%) had policies for filgrastim and 42 (84%) has policies for pegfilgrastim....For filgrastim biosimilars, 32 (84%) payers preferred Zarxio (filgrastim-sndz), which was the first biosimilar approved in the US. Nivestym (filgrastim-aafi) was the second most preferred filgrastim product, with 14 (37%) payers selecting it as the preferred product....Regarding pegfilgrastim biosimilars, 62% (n = 26) of payers preferred Ziextenzo, 60% (n = 25) preferred Neulasta, 55% (n = 23) preferred Fulphila."
Reimbursement • Oncology
April 09, 2024
Changes in US payer biosimilar coverage policies of granulocyte colony-stimulating factor products
(AMCP 2024)
- "For filgrastim biosimilars, 84% of payers preferred Zarxio, whereas Neupogen, Nivestym, and Releuko were most commonly nonpreferred...For pegfilgrastim biosimilars, 62% of payers preferred Ziextenzo, 60% preferred Neulasta, and 55% preferred Fulphila, whereas Nyvepria, Fylnetra, and Stimufend were most commonly nonpreferred. Prefer- ence for Udenyca was split, with 45% of payers preferring this agent and 45% of payers listing it as nonpreferred... Payer policies for granulocyte colony stimu- lating factor biosimilars indicated that Neulasta has retained much of its preferred status, whereas Neupogen is often nonpreferred. In both cases, average time to policy addition was about 4 months after FDA approval. Further, pegfil- grastim policies had more updates to the preferred product status than filgrastim policies, possibly because of more pegfilgrastim biosimilars being approved and marketed."
April 07, 2024
Evaluating the Effectiveness and Cost of Filgrastim Biosimilar at Loma Linda University Medical Center
(HOPA 2024)
- "Background/rationale: The purpose of this study is to determine the effectiveness and cost associated with the use of filgrastim (Neupogen) and filgrastim biosimilar (Zarxio) for patients admitted at Loma Linda University Medical Center (LLUMC)... Data collection and analysis are in process and conclusion/discussion will be reported in detail at the time of presentation."
Hematological Disorders • Neutropenia
March 08, 2024
Aplastic Anaemia Associated with Bendamustine Therapy - A Rare Side Effect.
(PubMed, Eur J Case Rep Intern Med)
- "Bendamustine can cause severe autoimmune haemolytic anaemia and aplastic anaemia, a side effect which has rarely been reported but is of significant clinical importance.Drug-induced aplastic anaemia is a complex, potentially devastating consequence of treating blood cancers and is a relatively unexplored area that requires further understanding.Anti-thymocyte globulin is effective in treating bendamustine-induced aplastic anaemia as it degrades lymphocytes that destroy the bone marrow."
Adverse events • Journal • Anemia • Aplastic Anemia • Autoimmune Hemolytic Anemia • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Immunology • Indolent Lymphoma • Infectious Disease • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Septic Shock
February 25, 2024
Filgrastim biosimilar (EP2006): a review of 15 years' post-approval evidence.
(PubMed, Crit Rev Oncol Hematol)
- "Additional real-world evidence studies have also demonstrated equivalent efficacy and safety of EP2006 compared with reference filgrastim, both in the reduction of neutropenia and in stem cell mobilization in clinical practice. This review summarizes these preclinical, clinical, and real-world data, as well as the available cost-effectiveness data, for EP2006 since its approval 15 years ago."
Journal • Review • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • Neutropenia
February 14, 2024
STEM CELL MOBILIZATION IN MULTIPLE MYELOMA: DESCRIPTIVE ANALYSIS AND PREDICTIVE FACTORS FOR STEM CELL MOBILIZATION FAILURE
(EBMT 2024)
- " A multicenter, observational and retrospective study was performed, including 124 patients with MM who performed stem cell mobilization from January 2019 to October 2023.Patients received Zarzio® (filgastrim) 10-15 µg/kg/day sc for 5 days, using Plerixafor in case of CD34+ < 10/ µg on day +4. Previous use of Lenalidomide and Daratumumab hinders the mobilization of hematopoietic progenitors. A higher number of cycles received and a shorter rest time between treatment and mobilization is associated with worse mobilization. Higher myeloma tumor burden and lower body weight are also factors for insufficient mobilization."
Biomarker • Bone Marrow Transplantation • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation • CD34
December 27, 2023
Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
(clinicaltrials.gov)
- P2 | N=270 | Recruiting | Sponsor: M.D. Anderson Cancer Center | N=200 ➔ 270
Enrollment change • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology
December 28, 2023
Filgrastim and infliximab biosimilar uptake in Medicare Advantage compared with Traditional Medicare, 2016-2019.
(PubMed, J Manag Care Spec Pharm)
- "We compare quarterly biosimilar uptake from 2016 to 2019 for the first 2 drugs with biosimilar competition: (1) filgrastim, (Neupogen, originator), and biosimilars tbo-filgrastim (GRANIX) and filgrastim-sndz (ZARXIO), and (2) infliximab (Remicade, originator), and biosimilars infliximab-dyyb (Inflectra) and infliximab-abda (Renflexis). Our findings suggest that filgrastim and infliximab biosimilar uptake is greater in MA compared with Traditional Medicare, which is driven in part by particularly high uptake of biosimilars in MA Kaiser HMO plans. This highlights the need for future work to examine specific strategies and levers employed by MA Kaiser HMO plans and other insurers to increase biosimilar uptake, which can lead to cost savings for physician-administered drugs."
Journal • Medicare • Reimbursement • US reimbursement
October 31, 2023
Long-Term Real-World Post-approval Safety Data of Multiple Biosimilars from One Marketing-Authorization Holder After More than 18 Years Since Their First Biosimilar Launch.
(PubMed, Drug Saf)
- "This is one of the largest reviews of post-approval biosimilar pharmacovigilance data to date by one MAH. The real-world experience of all eight marketed Sandoz biosimilars for up to 18 years demonstrates that Sandoz biosimilars can be used as safely as their respective reference biologics. Therefore, patients and healthcare providers can be confident in the clinical benefit and safety of Sandoz biosimilars. It is reasonable to believe that similar conclusions about safety may be reached for other biosimilars developed and approved to the high standards as are already in place by major health authorities such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). The long-term safety of biosimilars demonstrated here provides strong support for the concept of biosimilarity."
Biosimilar launch • Journal • Real-world • Real-world evidence
October 16, 2023
Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
(clinicaltrials.gov)
- P2 | N=200 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Dec 2024
Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology
May 22, 2023
Provider Barriers in Uptake of Biosimilars: Case Study on Filgrastim
(AJMC)
- "In this study, we offer a first look at an underappreciated source of disparities in access to lower-cost biologic drugs. Individuals living in rural areas, including a significant proportion of Americans 65 years and older,9 may have fewer choices of hospitals than those living in urban areas, and they typically seek care in hospitals with RRC or RHC designations. Without access to lower-cost biosimilars, they may end up paying more for some high-cost treatments. As more biosimilars enter the market, results of our study reveal opportunities for targeted policies to encourage adoption of lower-cost treatments, particularly among hospitals treating older patients with fewer choices in care site."
Online posting
May 07, 2023
Effectiveness of biosimilar pegfilgrastim in patients with multiple myeloma after high-dose melphalan and autologous stem cell transplantation.
(PubMed, Ann Hematol)
- "Novel supportive therapies (e.g., granulocyte colony-stimulating factor) have significantly improved post-ASCT-related mortality; however, data on biosimilar pegfilgrastim-bmez (BIO/PEG) in this setting is lacking. This prospective cohort study compared Italian patients with MM who received BIO/PEG post-ASCT with data collected retrospectively from historical control groups from the same center who received either filgrastim-sndz (BIO/G-CSF) or pegfilgrastim (PEG; originator)...Patients on BIO/PEG had less frequent grade 2-3 diarrhea (5.5%) compared with BIO/G-CSF (22.5%) or PEG (21.9%); grade 2-3 mucositis was most frequent in the BIO/G-CSF group. In conclusion, pegfilgrastim and its biosimilar displayed an advantageous efficacy and safety profile compared with biosimilar filgrastim in patients with MM post-ASCT."
Journal • Bone Marrow Transplantation • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Mucositis • Multiple Myeloma • Neutropenia • Oncology • Transplantation
February 12, 2023
GENERIC/BIOSIMILAR G-CSF ARE EFFECTIVE FOR PERIPHERAL BLOOD STEM CELL MOBILIZATION AND NON-CRYOPRESERVED AUTOLOGOUS TRANSPLANTATION IN MULTIPLE MYELOMA. A SINGLE CENTER EXPERIENCE IN ORAN (ALGERIA)
(EBMT 2023)
- "140 pts (group 1, G1) were received originator G-CSF (Neupogen®, or Granocyte®) and 147 pts (group 2, G2) received generic/biosimilar (Zarzio® 23pts, immunef (copy) 124 pts)... There was no difference between the characteristics of the pts of G1 and G2 in terms of age 59 years (33-77 years) vs 52 years (29-67 years) (p=0.54), sex-ratio male/female 0.6 vs 0.58, and treatment with lenalidomide before ASCT; 12 pts (9%) vs 10 pts (7%) (p= 0.62) respectively. Biosimilar/Generic G-CSF are as effective as originator G-CSF in mobilizing PBSCs in pts undergoing no cryopreserved storage ASCT for MM."
Clinical • Bone Marrow Transplantation • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation • CD34
December 05, 2018
Plinabulin, a Novel Small Molecule in Development for Chemotherapy-Induced-Neutropenia (CIN) Prevention, Mobilizes CD34+ Cells through a Mechanism of Action (MoA) Different from G-CSF and from CXCR4 Inhibition
(ASH 2018)
- P2/3; "...Single-dose-per-cycle Plin and pegfilgrastim (Peg) are equally effective for the prevention of Docetaxel (Doc)-induced grade 4 Neutropenia in NSCLC pts (Blayney; ASCO 2018; ASH 2016)...Plerixafor (Pler), a chemokine receptor 4 (CXCR4) antagonist, inhibits CXCR4/SDF-1 binding facilitating CD34+ cell mobilization...Peak CD34+ blood cell counts with G-CSF was ~6 cells/μL (Zarxio FDA Briefing Book, 2015)...Furthermore CD34+ cell counts after D8 are likely to increase further with Plin, but this was not measured in this study. Based on current data evidence, Plin has the potential to become a viable option for the mobilization of CD34+ cells from the bone marrow prior to HCT, in particular in pts failing to respond to G-CSF or G-CSF/Pler."
Biosimilar • Hematological Disorders • Hematological Malignancies • Lung Cancer • Multiple Myeloma • Neutropenia • Non Small Cell Lung Cancer • Oncology • Pain • Thoracic Cancer • Transplantation
May 20, 2017
Safety profile of EP2006 biosimilar filgrastim: A combined analysis of two independent phase III studies.
(ASCO 2017)
- P3; "...Study 1 (US registration trial) was a randomized, double-blind comparative study of biosimilar and reference filgrastim (Neupogen, Amgen) in women ≥18 years with breast cancer receiving (neo)adjuvant treatment for 6 consecutive cycles with TAC (docetaxel 75 mg/m2, doxorubicin 50 mg/m2, and cyclophosphamide 500 mg/m2)... Safety data for biosimilar filgrastim EP2006 is consistent with reference filgrastim in women with breast cancer undergoing myelotoxic chemotherapy."
Clinical • P3 data • Biosimilar • Breast Cancer • Pain
May 20, 2017
Safety and efficacy of alternating treatment with EP2006, a filgrastim biosimilar, and reference filgrastim for the prevention of severe neutropenia, in patients with breast cancer receiving myelosuppressive chemotherapy.
(ASCO 2017)
- P3; "There was no evidence of clinically meaningful differences when patients with breast cancer were switched from reference to biosimilar filgrastim, or from biosimilar to reference filgrastim."
Clinical • Biosimilar • Breast Cancer • Immunology • Pain
March 04, 2023
Comparison of Biosimilar Filgrastim with Innovator Fligrastim for Peripheral Blood Stem Cells Mobilization, Collection of CD34+ Stem Cells, and Engraftment in Patients Undergoing Autologous and Allogeneic Stem Cell Transplantation: A Single-Center Experience.
(PubMed, Ann Transplant)
- "There was no difference with regards to secondary outcomes between the 2 groups. CONCLUSIONS Our study showed that biosimilar G-CSF (Zarzio®) has comparable efficacy to the original G-CSF (Neupogen®) when used for mobilization in both autologous and allogenic stem cell transplantation and was associated with significant cost saving."
Journal • Retrospective data • Bone Marrow Transplantation • Oncology • Transplantation • CD34 • CSF3
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