- |||||||||| Neupogen (filgrastim) / Kyowa Kirin, Amgen, Zarxio (filgrastim-sndz) / Sandoz
Journal, Real-world evidence, Real-world: Real world comparison of filgrastim to filgrastim-sndz in patients with chemotherapy-induced neutropenia. (Pubmed Central) - Oct 23, 2024
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. filgrastim-sndz significantly reduced healthcare utilization costs compared to reference filgrastim with similar effect on absolute neutrophil count, incidence of fever, and febrile neutropenia.
- |||||||||| Neupogen (filgrastim) / Kyowa Kirin, Amgen, Zarxio (filgrastim-sndz) / Sandoz, Mylotarg (gemtuzumab ozogamicin) / Pfizer
Trial completion date, Trial primary completion date: 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) - Sep 20, 2024
P2, N=270, Recruiting,
filgrastim-sndz significantly reduced healthcare utilization costs compared to reference filgrastim with similar effect on absolute neutrophil count, incidence of fever, and febrile neutropenia. Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2026
- |||||||||| A CASE OF REFRACTORY IMMUNE THROMBOCYTOPENIA IN THE SETTING OF ABDOMINAL SPLENOSIS (Convention Center Exhibit Hall: Rapid Fire Area 2B) - Jul 31, 2024 - Abstract #CHEST2024CHEST_4985;
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 explore the connection between recurrent ITP with patients with presence of abdominal splenosis.
- |||||||||| Zarxio (filgrastim-sndz) / Sandoz
Review, Journal: Filgrastim biosimilar (EP2006): a review of 15 years' post-approval evidence. (Pubmed Central) - Apr 8, 2024
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.
- |||||||||| bendamustine / Generic mfg.
Journal, Adverse events: Aplastic Anaemia Associated with Bendamustine Therapy - A Rare Side Effect. (Pubmed Central) - Mar 8, 2024
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. 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.
- |||||||||| Darzalex (daratumumab) / J&J, Zarxio (filgrastim-sndz) / Sandoz
STEM CELL MOBILIZATION IN MULTIPLE MYELOMA: DESCRIPTIVE ANALYSIS AND PREDICTIVE FACTORS FOR STEM CELL MOBILIZATION FAILURE (ePoster area) - Feb 14, 2024 - Abstract #EBMT2024EBMT_2572;
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. 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
- |||||||||| Renflexis (infliximab-abda) / Yuhan Corp, Biogen, Ewopharma, Samsung, Organon
Reimbursement, US reimbursement, Journal, Medicare: Filgrastim and infliximab biosimilar uptake in Medicare Advantage compared with Traditional Medicare, 2016-2019. (Pubmed Central) - Jan 2, 2024
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.
- |||||||||| Neupogen (filgrastim) / Kyowa Kirin, Amgen, Zarxio (filgrastim-sndz) / Sandoz, Mylotarg (gemtuzumab ozogamicin) / Pfizer
Enrollment change: 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) - Dec 26, 2023
P2, N=270, Recruiting,
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. N=200 --> 270
- |||||||||| Neupogen (filgrastim) / Kyowa Kirin, Amgen, Zarxio (filgrastim-sndz) / Sandoz, Mylotarg (gemtuzumab ozogamicin) / Pfizer
Trial completion date, Trial primary completion date: 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) - Oct 16, 2023
P2, N=200, Recruiting,
The long-term safety of biosimilars demonstrated here provides strong support for the concept of biosimilarity. Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
- |||||||||| Ziextenzo (pegfilgrastim-bmez) / Novartis, Neulasta (pegfilgrastim) / Amgen, Kyowa Kirin, Roche
Retrospective data, Journal: Effectiveness of biosimilar pegfilgrastim in patients with multiple myeloma after high-dose melphalan and autologous stem cell transplantation. (Pubmed Central) - Jun 14, 2023
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.
- |||||||||| Neupogen (filgrastim) / Kyowa Kirin, Amgen, Zarxio (filgrastim-sndz) / Sandoz, Mylotarg (gemtuzumab ozogamicin) / Pfizer
Trial completion date, Trial primary completion date: 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) - Feb 13, 2023
P2, N=200, Recruiting,
CONCLUSIONS Our study showed that biosimilar G-CSF (Zarzio Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023
- |||||||||| Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
A Retrospective Analysis of Prophylactic G-CSF Biosimilar and Originator Administrative Claims over Time Among Patients with Non-Hodgkin Lymphoma () - Nov 29, 2022 - Abstract #ASH2022ASH_8072;
Of 2,094 (81%) patients who received high-risk chemotherapy, 1,919 (92%) received pegfilgrastim, 71 (3%) pegfilgrastim-cbqv, 49 (2%) pegfilgrastim-jmdb, 21 (<1%) filgrastim, 20 (<1%) filgrastim-sndz, and 14 (<1%) tbo-filgrastim or a combination of products...The most common chemotherapy regimens included cyclophosphamide/doxorubicin/vincristine/rituximab (n=1,304), bendamustine/rituximab (n=469), cyclophosphamide/rituximab (n=119), cyclophosphamide/doxorubicin/vincristine (n=105), rituximab (n=101), doxorubicin/vinblastine (n=91), and cyclophosphamide/doxorubicin/etoposide/vincristine/rituximab (n=46)...Pegfilgrastim biosimilar uptake occurred following market availability. Within each G-CSF product, most patients received the same product during the second cycle of chemotherapy rather than switching products.
- |||||||||| Neupogen (filgrastim) / Kyowa Kirin, Amgen, Zarxio (filgrastim-sndz) / Sandoz, Mylotarg (gemtuzumab ozogamicin) / Pfizer
Trial completion date, Trial primary completion date: 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) - Jul 28, 2022
P2, N=200, Recruiting,
Within each G-CSF product, most patients received the same product during the second cycle of chemotherapy rather than switching products. Trial completion date: Apr 2022 --> Dec 2022 | Trial primary completion date: Apr 2022 --> Dec 2022
- |||||||||| Zarzio (filgrastim biosimilar) / Novartis
Clinical, Reimbursement, Journal, Medicare, Medicaid: Uptake and cost of biosimilar filgrastim among Medicare and Medicaid populations in 2015-2018. (Pubmed Central) - Nov 11, 2021
BACKGROUND: The first biosimilar product filgrastim-sndz was approved by the FDA in 2015, but real-world evaluations of its uptake and cost in nationally representative populations are limited...DISCLOSURES: No outside funding supported this work. The author has no conflicts of interest to disclose.
- |||||||||| Neupogen (filgrastim) / Kyowa Kirin, Amgen, Zarzio (filgrastim biosimilar) / Novartis
Clinical, Review, Journal: Pleomorphicskin eruptions in a COVID-19 affected patient: Case report and review of the literature. (Pubmed Central) - Sep 30, 2021
The patient stopped all treatment but oxygen and enoxaparin were continued and the patient received a high-dose Desametasone with complete remission of dermatological impairment in 10 days. It is very important to differentially diagnose COVID-19 disease-related cutaneous manifestations, where is justified to continue the multidrug antiviral treatment, from those caused by an adverse drug reaction, where it would be necessary to identify the possible culprit drug and to start appropriate antiallergic treatment.
- |||||||||| Zarzio (filgrastim biosimilar) / Novartis
Retrospective data, Journal, HEOR: Site of care potentially limits cost savings from biosimilars. (Pubmed Central) - Sep 26, 2021
Although previous work has found lower costs for biosimilar filgrastim compared with reference filgrastim, here we found that site of care can change this calculus, reducing savings. After adjusting for patient characteristics and geography, we found that drug cost savings for biosimilar filgrastim were limited to the office setting, with no savings in the outpatient hospital setting.
- |||||||||| Zarzio (filgrastim biosimilar) / Novartis
Clinical, Journal, HEOR: Primary Prophylaxis With Biosimilar Filgrastim for Patients at Intermediate Risk for Febrile Neutropenia: A Cost-Effectiveness Analysis. (Pubmed Central) - Aug 15, 2021
PP with a biosimilar filgrastim (specifically filgrastim-sndz) is cost-effective in patients with intermediate risk for FN receiving curative chemotherapy regimens for breast cancer, NSCLC, and NHL. Expanding the use of colony-stimulating factors for patients may be valuable in reducing unnecessary health care visits for patients with cancer at risk of complications because of COVID-19 and should be considered for the indefinite future.
- |||||||||| Neupogen (filgrastim) / Kyowa Kirin, Amgen, Zarxio (filgrastim-sndz) / Sandoz, Starasid (cytarabine ocfosfate) / Nippon Kayaku
Trial completion, Enrollment change: Donor Natural Killer Cells in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - Jun 21, 2021
P1/2, N=30, Completed,
In conclusion, the biosimilar product was non-inferior for mobilization and the conversion from filgrastim to filgrastim-sndz afforded patients similar efficacy for mobilization in stem cell transplant at a reduced cost. Recruiting --> Completed | N=44 --> 30
- |||||||||| Zarzio (filgrastim biosimilar) / Novartis
Journal: Provider differences in biosimilar uptake in the filgrastim market. (Pubmed Central) - May 6, 2021
This study uncovers important associations between provider practice characteristics and biosimilar uptake. Our findings suggest that provider awareness and incentives can be important levers to strengthen US biosimilar market penetration and competition.
- |||||||||| Neupogen (filgrastim) / Kyowa Kirin, Amgen, Zarxio (filgrastim-sndz) / Sandoz, Mylotarg (gemtuzumab ozogamicin) / Pfizer
Trial completion date: 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) - Apr 28, 2021
P2, N=200, Recruiting,
Our findings suggest that provider awareness and incentives can be important levers to strengthen US biosimilar market penetration and competition. Trial completion date: Apr 2023 --> Apr 2022
- |||||||||| Neupogen (filgrastim) / Kyowa Kirin, Amgen, Zarxio (filgrastim-sndz) / Sandoz, Mylotarg (gemtuzumab ozogamicin) / Pfizer
Trial completion date, Trial primary completion date: 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) - Apr 22, 2021
P2, N=200, Recruiting,
Data on identification of biosimilars in claims data and observed gaps between exposure episodes can be used to support drug safety studies of biosimilars. Trial completion date: Apr 2020 --> Apr 2023 | Trial primary completion date: Apr 2020 --> Apr 2022
- |||||||||| Zarzio (filgrastim biosimilar) / Novartis, Neulasta (pegfilgrastim) / Amgen, Kyowa Hakko Kirin, Roche
[VIRTUAL] Real World Risk of Splenic Rupture with G-CSF/GM-CSF Therapy: A Pharmacovigilance Assessment Using FDA Adverse Event Reporting System (FAERS) Database () - Nov 5, 2020 - Abstract #ASH2020ASH_4931;
ROR was calculated separately for Pegfilgrastim 16.03 (95% CI 11.90-21.59), Filgrastim (49.79; 36.32-68.26), Lenograstim (133.82; 55.39-323.32), Filgrastim-sndz (87.87; 28.21-273.71), Filgrastim+Pegfilgrastim (35.01; 11.26-108.85), Filgrastim+Sargramostim (895.20; 214.83-3730.27) and for all G-CSF/GM-CSF drugs taken together (28.13; 22.92-34.52)...Conclusion This study demonstrates disproportionately elevated signals of developing splenic rupture in patient receiving G-CSF/GM-CSF therapy as compared to those receiving other drugs based on the FAERS database. Physicians should be aware of this rare adverse event as it could potentially lead to life-threatening outcomes.
- |||||||||| Zarzio (filgrastim biosimilar) / Novartis
Reimbursement, Journal, Medicare: Biosimilar Filgrastim Uptake And Costs Among Commercially Insured, Medicare Advantage. (Pubmed Central) - Oct 28, 2020
Following rapid uptake, by March 2018 filgrastim-sndz accounted for 47 percent of filgrastim administrations among commercially insured and 42 percent among Medicare Advantage beneficiaries. The initial cost difference between the originator and biosimilar was 31 percent in the former population but negligible in the latter.
- |||||||||| Zarzio (filgrastim biosimilar) / Novartis
Journal: Towards a comprehensive safety understanding of granulocyte-colony stimulating factor biosimilars in treating chemotherapy associated febrile neutropenia: Trends from decades of data. (Pubmed Central) - Aug 18, 2020
Filgrastim, a biopharmaceutical listed on WHO model list of essential medicines, was approved in USA in 1991 for patients with non-myeloid malignancies associated with severe neutropenia and fever...Overall, 11,183 adverse drugs reaction reports were identified during observation period; of which 5764; 51.5% reports concerned to Neupogen®, the originator, and rest consists of Leucostim® (N = 680), Zarzio® (N = 622), Grasin® (N = 545), Nivestim® (N = 359) and Tevagrastim® (N = 152) biosimilars...Authors observed significant differences among originator and biosimilars in particular to efficacy, adverse events reported and time to onset of occurrences. Large epidemiologic studies are needed to further confirm these finding and provide additional insights.
- |||||||||| Zarzio (filgrastim biosimilar) / Novartis
Journal: The Era of Therapeutic Biosimilars Has Arrived: What You Need to Know. (Pubmed Central) - Aug 12, 2020
At the NCCN 2019 Annual Congress: Hematologic Malignancies, Dr. Andrew D. Zelenetz, Memorial Sloan Kettering Cancer Center, outlined important issues regarding the use of biosimilars, including extrapolation, interchangeability, and naming.
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