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https://www.readbyqxmd.com/read/27623036/mexican-biosimilar-filgrastim-for-autologous-hematopoietic-stem-cell-mobilization-and-transplantation
#1
Mónica León-González, Andrés A León-Peña, María Fernanda Vallejo-VIllalobos, Ana Karen Núñez-Cortés, Alejandro Ruiz-Argüelles, Guillermo J Ruiz-Argüelles
BACKGROUND: Following the release of the initial presentation of filgrastim (granulocyte colony-stimulating factor), several biosimilars have been developed worldwide. OBJECTIVE: To study the efficacy of a Mexican biosimilar granulocyte colony-stimulating factor in a single transplant center. METHODS: In a group of 19 consecutive patients with multiple sclerosis given autografts, we employed granulocyte colony-stimulating factors to mobilize stem cells from the bone marrow to the peripheral blood, either the original granulocyte colony-stimulating factor (n = 10) or a Mexican granulocyte colony-stimulating factor biosimilar (n = 9)...
July 2016: Revista de Investigación Clínica; Organo del Hospital de Enfermedades de la Nutrición
https://www.readbyqxmd.com/read/27565504/comparison-of-transplant-outcomes-and-economic-costs-between-biosimilar-and-originator-filgrastim-in-allogeneic-hematopoietic-stem-cell-transplantation
#2
Kaito Harada, Yuta Yamada, Tatsuya Konishi, Akihito Nagata, Toshiaki Takezaki, Satoshi Kaito, Shuhei Kurosawa, Masahiro Sakaguchi, Shunichiro Yasuda, Kosuke Yoshioka, Kyoko Watakabe-Inamoto, Aiko Igarashi, Yuho Najima, Takeshi Hagino, Hideharu Muto, Takeshi Kobayashi, Noriko Doki, Kazuhiko Kakihana, Hisashi Sakamaki, Kazuteru Ohashi
From January 2012 to September 2015, 49 patients received biosimilar filgrastim (BF) after allogeneic bone marrow transplantation (BMT, n = 31) or peripheral stem cell transplantation (PBSCT, n = 18) in our institution. To evaluate the clinical impact of BF on transplant outcomes of these patients, we compared hematological recovery, overall survival (OS), disease-free survival (DFS), transplantation-related mortality (TRM), cumulative incidence of relapse (CIR), and acute and chronic graft-versus-host disease (GVHD) with those of control patients who received originator filgrastim (OF) after BMT (n = 31) or PBSCT (n = 18)...
August 26, 2016: International Journal of Hematology
https://www.readbyqxmd.com/read/27509033/mobilization-of-autologous-and-allogeneic-peripheral-blood-stem-cells-for-transplantation-in-haematological-malignancies-using-biosimilar-g-csf
#3
M Schmitt, J-M Hoffmann, K Lorenz, A Publicover, A Schmitt, A Nagler
BACKGROUND AND OBJECTIVES: Biosimilars of the granulocyte colony stimulating factor (G-CSF) filgrastim were approved by the European Medicines Agency (EMA) for registered indications of the originator G-CSF, including prevention and treatment of neutropenia, as well as mobilization of peripheral blood stem cells in 2008. Nevertheless, there is still an ongoing debate regarding the quality, efficacy and safety of biosimilar G-CSF. MATERIALS AND METHODS: This article is a meta-analysis of clinical studies on the use of biosimilar G-CSF for mobilization and transplantation of haematopoietic stem cells as available in public databases...
August 2016: Vox Sanguinis
https://www.readbyqxmd.com/read/27458246/antitumor-effect-of-programmed-death-1-pd-1-blockade-in-humanized-the-nog-mhc-double-knockout-mouse
#4
Tadashi Ashizawa, Akira Iizuka, Chizu Nonomura, Ryota Kondou, Chie Maeda, Haruo Miyata, Takashi Sugino, Koichi Mitsuya, Nakamasa Hayashi, Yoko Nakasu, Kouji Maruyama, Ken Yamaguchi, Ikumi Katano, Mamoru Ito, Yasuto Akiyama
PURPOSE: Humanized mouse models using NOD/Shi-scid-IL2rγ(null) (NOG) and NOD/LtSz-scid IL2rγ(null) (NSG) mouse are associated with several limitations, such as long incubation time for stem cell engraftment and the development of xenograft versus host disease in mice injected with peripheral blood mononuclear cells (PBMCs). To solve problems, we used humanized major histocompatibility class I- and class II-deficient NOG mice (referred to as NOG-dKO) to evaluate the antitumor effect of anti-programmed death-1 (PD-1) antibody...
July 25, 2016: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/27183986/biosimilar-filgrastim-in-autologous-peripheral-blood-hematopoietic-stem-cell-mobilization-and-post-transplant-hematologic-recovery
#5
REVIEW
Francesco Marchesi, Andrea Mengarelli
To date, two kinds of Granulocyte Colony-Stimulating Factors (G-CSF) have been approved for autologous peripheral blood hematopoietic stem cell (PBSCs) mobilization and posttransplant hematologic recovery after high-dose chemotherapy: filgrastim (originator and biosimilar) and lenograstim. Biosimilar filgrastim has been approved on the basis of comparable efficacy and safety in clinical studies where it has been used as chemotherapy-induced febrile neutropenia prophylaxis, but no specific pre-registration studies have been published in the transplant setting...
2016: Current Medicinal Chemistry
https://www.readbyqxmd.com/read/27052362/evaluation-of-the-efficacy-and-safety-of-original-filgrastim-neupogen%C3%A2-biosimilar-filgrastim-leucostim%C3%A2-and-lenograstim-granocyte%C3%A2-in-cd34-peripheral-hematopoietic-stem-cell-mobilization-procedures-for-allogeneic-hematopoietic-stem-cell-transplant-donors
#6
Serdar Sivgin, Esen Karakus, Muzaffer Keklik, Gokmen Zararsiz, Musa Solmaz, Leylagul Kaynar, Bulent Eser, Mustafa Cetin, Ali Unal
OBJECTIVES AND AIM: In this study, we aimed to compare the potency of different G-CSF agents including original filgrastim (Neupogen®), biosimilar filgrastim (Leucostim®) and Lenograstim (Granocyte®) on CD34(+) cell mobilization in patients that underwent allogeneic hematopoietic stem cell transplantation (alloHSCT). PATIENTS AND METHODS: The data of 243 donors for alloHSCT recipients diagnosed with mostly acute leukemia and myelodsyplastic syndromes (MDS) were analyzed, retrospectively...
June 2016: Transfusion and Apheresis Science
https://www.readbyqxmd.com/read/27023705/tbo-filgrastim-a-review-in-neutropenic-conditions
#7
Hannah A Blair, Lesley J Scott
Tbo-filgrastim (filgrastim XM02; Biograstim(®), Ratiograstim(®), Tevagrastim(®)) is approved in the EU as a biosimilar of filgrastim (Neupogen(®)) for use in all indications for which reference filgrastim is approved, including chemotherapy-induced neutropenia, neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation, mobilization of peripheral blood stem cells (PBSCs), severe chronic neutropenia, and neutropenia in HIV infection. Tbo-filgrastim (Granix(®)) is also approved as a biologic in the USA for neutropenia associated with chemotherapy...
April 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/27001243/efficacious-and-save-use-of-biosimilar-filgrastim-for-hematopoietic-progenitor-cell-chemo-mobilization-with-vinorelbine-in-multiple-myeloma-patients
#8
Julia-Tatjana Maul, Frank Stenner-Liewen, Burkhardt Seifert, Sarah Pfrommer, Ulf Petrausch, Michael K Kiessling, Urs Schanz, Gayathri Nair, Axel Mischo, Christian Taverna, Adrian Schmidt, Mario Bargetzi, Roger Stupp, Christoph Renner, Panagiotis Samaras
Biosimilars are increasingly being licensed as equipotent drugs, although efficacy and safety data are not available for all clinical indications. Accordingly, the efficacy of the biosimilar filgrastim Zarzio® combined with vinorelbine for chemo-mobilization of CD34+ hematopoietic progenitor cells (HPC) in patients with multiple myeloma has not been evaluated yet. We compared the efficacy of vinorelbine combined with this biosimilar filgrastim for HPC mobilization to vinorelbine plus original filgrastim (Neupogen®)...
March 22, 2016: Journal of Clinical Apheresis
https://www.readbyqxmd.com/read/26343949/biosimilar-filgrastim-tevagrastim-xmo2-for-allogeneic%C3%A2-hematopoietic-stem-cell-mobilization-and%C3%A2-transplantation-in-patients-with-acute-myelogenous%C3%A2-leukemia-myelodysplastic-syndromes
#9
Ivetta Danylesko, Rina Sareli, Nira Bloom-Varda, Ronit Yerushalmi, Noga Shem-Tov, Avichai Shimoni, Arnon Nagler
Human recombinant granulocyte colony-stimulating factor (G-CSF), filgrastim (Neupogen; Amgen, Thousand Oaks, CA, USA), has been widely used for the mobilization of CD34(+) hematopoietic stem cells (HSC) from healthy donors. The experience with biosimilar G-CSF agents in this area is limited. We performed a prospective study assessing Tevagrastim (biosimilar filgrastim, XMO2; Teva, Israel) for mobilization of CD34(+) peripheral blood HSC in HLA-matched healthy sibling donors for transplantation in 24 patients with acute myelogenous leukemia (AML) and high-risk myelodysplastic syndromes (MDS) (NCT01542944)...
February 2016: Biology of Blood and Marrow Transplantation
https://www.readbyqxmd.com/read/26188967/efficacy-of-biosimilar-granulocyte-colony-stimulating-factor-versus-originator-granulocyte-colony-stimulating-factor-in-peripheral-blood-stem-cell-mobilization-in-de-novo-multiple-myeloma-patients
#10
COMPARATIVE STUDY
Massimo Martino, Anna Grazia Recchia, Tiziana Moscato, Roberta Fedele, Santo Neri, Massimo Gentile, Caterina Alati, Iolanda Donatella Vincelli, Eugenio Piro, Giuseppa Penna, Caterina Musolino, Francesca Ronco, Stefano Molica, Fortunato Morabito
BACKGROUND AIMS: Filgrastim and lenograstim are the standard granulocyte colony-stimulating factor (G-CSF) agents for peripheral blood stem cell mobilization (PBSC) in patients who undergo autologous stem cell transplantation. METHODS: To assess whether biosimilars are effective, we conducted a single-center, prospective study that included 40 consecutive de novo multiple myeloma patients who received cyclophosphamide 4 g/m(2) per day plus biosimilar filgrastim G-CSF to mobilize PBSC...
October 2015: Cytotherapy
https://www.readbyqxmd.com/read/26173921/comparison-of-biosimilar-filgrastim-with-originator-filgrastim-for-peripheral-blood-stem-cell-mobilization-and-engraftment-in-patients-with-multiple-myeloma-undergoing-autologous-stem-cell-transplantation
#11
Tina Pham, Sushrut Patil, Shaun Fleming, Sharon Avery, Patricia Walker, Andrew Wei, David Curtis, Georgia Stuart, Daniela Klarica, Maureen O'Brien, Karen Morris, Tongted Das, Geraldine Bollard, Jennifer Muirhead, John Coutsouvelis, Andrew Spencer
BACKGROUND: Nivestim is a biosimilar approved for the same indications as Neupogen including the mobilization of autologous peripheral blood stem cells (PBSCs). The clinical efficacy and safety of Nivestim for this use have not been formally assessed in clinical trials. STUDY DESIGN AND METHODS: In our retrospective single-center study we compared variables of PBSC mobilization and engraftment of 60 patients mobilized with Nivestim to that of 38 patients mobilized with Neupogen...
November 2015: Transfusion
https://www.readbyqxmd.com/read/26011178/mobilization-of-hematopoietic-progenitor-cells-from-allogeneic-healthy-donors-using-a-new-biosimilar-g-csf-zarzio%C3%A2
#12
COMPARATIVE STUDY
María Luisa Antelo, Amaya Zabalza, María Piva Sánchez Antón, Saioa Zalba, Mariví Aznar, Cristina Mansilla, Natalia Ramírez, Eduardo Olavarría
Peripheral blood progenitor cells (PBPCs) have become the major source of hematopoietic progenitor cells for allogeneic transplantation. In February 2008, Zarzio® was approved by the European Medicine Agency for PBPCs mobilization, but this authorization was not based in trials analyzing safety and efficacy for PBPCs mobilization. Since August 2011, Zarzio® has been used at our institution for PBPCs mobilization. In total 36 healthy family donors underwent PBPCs mobilization, 18 with Neupogen® and 18 with Zarzio®...
February 2016: Journal of Clinical Apheresis
https://www.readbyqxmd.com/read/25830013/use-of-biosimilar-filgrastim-compared-with-lenograstim-in-autologous-haematopoietic-stem-cell-transplant-and-in-sibling-allogeneic-transplant
#13
Shab Uddin, Pippa Russell, Maresa Farrell, Barbara Davy, Joe Taylor, Samir G Agrawal
OBJECTIVES: Biosimilar filgrastim was compared with lenograstim for autologous haematopoietic stem-cell transplant (HSCT) in patients with haematological malignancies. Data from a separate group of sibling donors who underwent allogeneic HSCT are also reported. METHODS: Patients with lymphoma or multiple myeloma (MM) who underwent autologous HSCT with biosimilar filgrastim were compared with a historical control group of patients who received lenograstim. Peripheral blood (PB) cells counts were monitored after 7-8 consecutive days of granulocyte-colony stimulating factor (G-CSF) injection and apheresis was performed on day 8 if PB CD34+ cell count was ⩾10 cells/µl...
April 2015: Therapeutic Advances in Hematology
https://www.readbyqxmd.com/read/25818943/the-safety-efficacy-and-regulatory-triangle-in-drug-development-impact-for-animal-models-and-the-use-of-animals
#14
REVIEW
Peter J K van Meer, Melanie L Graham, Henk-Jan Schuurman
Nonclinical studies in animals are conducted to demonstrate proof-of-concept, mechanism of action and safety of new drugs. For a large part, in particular safety assessment, studies are done in compliance with international regulatory guidance. However, animal models supporting the initiation of clinical trials have their limitations, related to uncertainty regarding the predictive value for a clinical condition. The 3Rs principles (refinement, reduction and replacement) are better applied nowadays, with a more comprehensive application with respect to the original definition...
July 15, 2015: European Journal of Pharmacology
https://www.readbyqxmd.com/read/25761321/safety-and-efficacy-of-granulocyte-colony-stimulating-factor-biosimilars-in-engraftment-after-autologous-stem-cell-transplantation-for-haematological-malignancies-a-4-year-single-institute-experience-with-different-conditioning-regimens
#15
Simona Bassi, Elisa M Stroppa, Carlo F Moroni, Maria C Arbasi, Elena Trabacchi, Anna Di Franco, Antonio Lazzaro, Patrizia Bernuzzi, Mauro Moretto, Annalisa Arcari, Costanza Bosi, Alessandra Riva, Luigi Cavanna, Daniele Vallisa
BACKGROUND: Filgrastim biosimilars have recently been introduced into clinical practice. To date biosimilars have demonstrated comparable efficacy and safety as the originator in chemotherapy-induced neutropenia. Published experience in engraftment after autologous stem cell transplantation (ASCT) is limited and concerns relatively few patients. MATERIALS AND METHODS: With the aim of assessing the efficacy and the safety of filgrastim biosimilars in post-ASCT bone marrow recovery, we conducted a single institution, retrospective study in 56 lymphoma and myeloma patients who received filgrastim biosimilars (Tevagrastim(®) and Zarzio(®)) at standard doses from day 5...
July 2015: Blood Transfusion, Trasfusione del Sangue
https://www.readbyqxmd.com/read/25683185/biosimilar-biologics-never-identical-but-close-enough
#16
EDITORIAL
Rita Abi-Raad, Brian R Smith
No abstract text is available yet for this article.
February 2015: Transfusion
https://www.readbyqxmd.com/read/25380941/biosimilar-granulocyte-colony-stimulating-factor-is-effective-in-reducing-the-duration-of-neutropenia-after-autologous-peripheral-blood-stem-cell-transplantation
#17
M Cioch, D Jawniak, K Kotwica, M Wach, J Mańko, A Gorący, P Klimek, E Mazurkiewicz, P Jarosz, M Hus
BACKGROUND: Autologous peripheral blood stem cell transplantation (APBSCT) is the standard of therapy for patients with multiple myeloma and refractory Hodgkin's and non-Hodgkin's lymphomas. Granulocyte colony-stimulating factor (G-CSF) is widely used to accelerate hematopoietic recovery after transplantation and to reduce the morbidity and mortality associated with prolonged neutropenia. Biosimilar G-CSF is approved for the same indications as the originator G-CSF. This is one of the first reported uses of a biosimilar G-CSF for neutrophil recovery after APBSCT...
October 2014: Transplantation Proceedings
https://www.readbyqxmd.com/read/25242760/efficacy-of-subcutaneous-epoetin-zeta-on-anemia-in-renal-transplant-recipients-a-single-center-experience
#18
M Sabbatini, S Vitale, G Garofalo, M Torino, R Gallo, R Carrano, S Federico
BACKGROUND: Persistent or "de novo" anemia (plasma hemoglobin<11 g/dL) may complicate the graft outcome in a significant number of renal transplant recipients. We describe a single-center experience with epoetin-zeta (EPO-Z), the biosimilar form for epoetin-alfa. METHODS: Twenty patients were included in the study, 10 in treatment with different erythropoiesis-stimulating agents (ESA) and shifted to EPO-Z (shift group) and 10 who started EPO-Z treatment for anemia (naive group)...
September 2014: Transplantation Proceedings
https://www.readbyqxmd.com/read/25070657/biosimilar-granulocyte-colony-stimulating-factor-for-mobilization-of-autologous-peripheral-blood-stem-cells-in-pediatric-hematology-oncology-patients
#19
MULTICENTER STUDY
Simone Cesaro, Gloria Tridello, Arcangelo Prete, Sandro Dallorso, Elisa Cannata, Erika Massaccesi, Marco Risso, Massimiliano De Bortoli, Désirée Caselli
BACKGROUND: Recently biosimilars of granulocyte-colony-stimulating factor (G-CSF) became available for prophylaxis and treatment of postchemotherapy neutropenia and for mobilization of peripheral blood CD34+ cells for either autologous or allogeneic hematopoietic stem cell transplant. Most of the data on the mobilization efficacy and safety of biosimilar G-CSF are from adult patients, whereas no data are available in pediatric patients. STUDY DESIGN AND METHODS: This was a retrospective study on cases treated at three Italian pediatric transplant centers, from January 2011 to October 2013...
February 2015: Transfusion
https://www.readbyqxmd.com/read/24965197/biosimilar-granulocyte-colony-stimulating-factor-for-healthy-donor-stem-cell-mobilization-need-we-be-afraid
#20
REVIEW
Halvard Bonig, Petra S Becker, Arnd Schwebig, Matthew Turner
Biosimilars are approved biologics with comparable quality, safety, and efficacy to a reference product. Unlike generics, which are chemically manufactured copies of small-molecule drugs with relatively simple chemical structures, the biosimilar designation is applied to drugs that are produced by living organisms, implying much more difficult to control manufacturing and purification procedures. To account for these complexities, the European Medicines Agency (EMA), the US Food and Drug Administration, the Australian Therapeutic Goods Administration, and other regulatory authorities have devised and implemented specific, markedly more demanding pathways for the evaluation and approval of biosimilars...
February 2015: Transfusion
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