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https://www.readbyqxmd.com/read/29687743/clinical-outcomes-of-treatment-with-filgrastim-versus-a-filgrastim-biosimilar-and-febrile-neutropenia-associated-costs-among-patients-with-nonmyeloid-cancer-undergoing-chemotherapy
#1
Lee S Schwartzberg, Lincy S Lal, Sanjeev Balu, Kim Campbell, Lee Brekke, Andrew DeLeon, Caitlin Elliott, Stephanie Korrer
BACKGROUND: Granulocyte colony-stimulating factors such as filgrastim are used to decrease the incidence of febrile neutropenia (FN) among patients with nonmyeloid cancers undergoing chemotherapy treatment. Although the biosimilar filgrastim-sndz has been approved in the United States since 2015, limited real-world comparisons of filgrastim-sndz versus reference filgrastim (filgrastim-ref) have been conducted. OBJECTIVE: To compare FN incidence and assess overall FN-related health care resource utilization and medical costs among U...
April 24, 2018: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29555414/medical-and-ethical-considerations-on-hematopoietic-stem-cells-mobilization-for-healthy-donors
#2
V Moalic-Allain
Hematopoietic stem cell transplantation is a common procedure potentially beneficial to many individuals with cancer, hematological, or inherited disorders, and has highlighted the need of related or unrelated donors to perform allograft. Donation of hematopoietic stem cells, either through bone marrow harvest or peripheral blood stem cell collection, is well-established and widespread. Over the past two decades, the peripheral blood stem cell collection by aphaeresis has become the main source of hematopoietic stem cells for transplantation, due to faster engraftment and practicability and lower risk of relapse for high-risk patients...
March 16, 2018: Transfusion Clinique et Biologique: Journal de la Société Française de Transfusion Sanguine
https://www.readbyqxmd.com/read/29515065/-efficacy-and-safety-of-biosimilar-filgrastim-for-autologous-peripheral-blood-stem-cell-harvest-and-transplantation-a-single-institutional-retrospective-analysis
#3
Masaki Iino, Takeo Yamamoto
Three biosimilar filgrastim products are currently available in Japan. Among these, the safety and efficacy of two imported drugs for autologous peripheral blood stem cell harvest (autoPBSCH) and autologous peripheral blood stem cell transplantation (autoPBSCT) have been studied widely; however, evidence of the safety and efficacy of domestically manufactured filgrastim is limited. Therefore, we compared the efficacy and safety of domestic biosimilar filgrastim (BF1, n=23) with those of originator filgrastim (OF, n=21) for autoPBSCH and autoPBSCT...
2018: [Rinshō Ketsueki] the Japanese Journal of Clinical Hematology
https://www.readbyqxmd.com/read/29422802/efficacy-and-safety-of-the-adalimumab-biosimilar-exemptia-as-induction-therapy-in-moderate-to-severe-ulcerative-colitis
#4
Vandana Midha, Ramit Mahajan, Varun Mehta, Vikram Narang, Arshdeep Singh, Kirandeep Kaur, Ajit Sood
Background/Aims: Data on the efficacy and safety of the adalimumab biosimilar Exemptia are limited. Methods: Patients with moderate-to-severe active steroid-refractory ulcerative colitis (UC) treated at Dayanand Medical College and Hospital, India were offered cyclosporine A, biologicals or biosimilars, or surgery. A retrospective analysis was conducted on patients who were treated with the adalimumab biosimilar, Exemptia. These patients were administered an induction dosing schedule of 160 mg Exemptia at week 0, 80 mg at week 2, and then 40 mg every other week from week 4 to 8...
January 2018: Intestinal Research
https://www.readbyqxmd.com/read/29398477/clinical-safety-and-efficacy-of-filgrastim-biosimilar-2-in-japanese-patients-in-a-post-marketing-surveillance-study
#5
Kazuo Tamura, Kazue Hashimoto, Kiyohiro Nishikawa
We conducted a post-marketing surveillance to evaluate the safety and efficacy of TKN732, approved as "filgrastim biosimilar 2", in Japanese patients who developed neutropenia in the course of cancer chemotherapy or hematopoietic stem cell transplantation. A total of 653 patients were registered during the 2-year enrollment period starting from May 2013, and 627 and 614 patients were eligible for safety and efficacy analyses of the G-CSF biosimilar, respectively. Forty-three adverse drug reactions were reported in 33 patients (5...
May 2018: Journal of Infection and Chemotherapy: Official Journal of the Japan Society of Chemotherapy
https://www.readbyqxmd.com/read/29153313/what-is-the-role-of-biosimilar-g-csf-agents-in-hematopoietic-stem-cell-mobilization-at-present
#6
Serdal Korkmaz, Fevzi Altuntas
Mobilization of hematopoietic stem cells, which has largely replaced bone marrow harvesting as a source of hematopoietic stem cells, using recombinant agents such as filgrastim or lenograstim has become a standard procedure in both patients and healthy donors prior to peripheral blood stem cell collection for autologous and allogeneic stem cell transplantation. Published literature data suggest that mobilization with recombinant granulocyte-colony stimulating factor (G-CSF) is safe and mobilization outcomes are satisfactory...
December 2017: Transfusion and Apheresis Science
https://www.readbyqxmd.com/read/29084409/a-comparison-of-the-safety-and-efficacy-of-hx575-epoetin-alfa-proposed-biosimilar-with-epoetin-alfa-in-patients-with-end-stage-renal-disease
#7
Matthew R Weir, Pablo E Pergola, Rajiv Agarwal, Jeffrey C Fink, Nelson P Kopyt, Ajay K Singh, Jayant Kumar, Susanne Schmitt, Gregor Schaffar, Anita Rudy, Jim P McKay, Radmila Kanceva
BACKGROUND: HX575 (biosimilar epoetin alfa) was approved in Europe in 2007 for the treatment of chronic kidney disease (CKD)-related anemia. This study assessed the clinical equivalence of HX575 with the US-licensed reference epoetin alfa (Epogen®/Procrit®, Amgen/Janssen) following subcutaneous (SC) administration in dialysis patients with CKD-related anemia. METHODS: This randomized, double-blind, parallel-group, multicenter study (NCT01693029) was conducted at 49 US clinical sites...
2017: American Journal of Nephrology
https://www.readbyqxmd.com/read/28990128/a-single-center-retrospective-analysis-to-compare-the-efficacy-and-safety-of-filgrastim-sndz-to-filgrastim-for-prophylaxis-of-chemotherapy-induced-neutropenia-and-for-neutrophil-recovery-following-autologous-stem-cell-transplantation
#8
Julia Zecchini, Kendra Yum, Amir Steinberg, Cardinale Smith, Sara Kim
Filgrastim-sndz (Zarxio®) was approved by the FDA in March 2015 as a biosimilar product of its reference product, filgrastim (Neupogen®) for all five indications. The NCCN Clinical Practice Guidelines has incorporated filgrastim-sndz into its recommendations as a category 1 recommendation for use in settings of febrile neutropenia, myelosuppressive chemotherapy administration, and post-hematopoietic stem cell transplant (HSCT). As a cost-saving initiative, our institution switched from filgrastim to filgrastim-sndz for all indications starting in March 2016...
March 2018: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
https://www.readbyqxmd.com/read/28797783/results-of-a-prospective-randomized-open-label-noninferiority-study-of-tbo-filgrastim-granix-versus-filgrastim-neupogen-in-combination-with-plerixafor-for-autologous-stem-cell-mobilization-in-patients-with-multiple-myeloma-and-non-hodgkin-lymphoma
#9
Pavan Kumar Bhamidipati, Mark A Fiala, Brenda J Grossman, John F DiPersio, Keith Stockerl-Goldstein, Feng Gao, Geoffrey L Uy, Peter Westervelt, Mark A Schroeder, Amanda F Cashen, Camille N Abboud, Ravi Vij
Autologous hematopoietic stem cell transplantation (auto-HSCT) improves survival in patients with multiple myeloma (MM) and non-Hodgkin lymphoma (NHL). Traditionally, filgrastim (Neupogen; recombinant G-CSF) has been used in as a single agent or in combination with plerixafor for stem cell mobilization for auto-HSCT. In Europe, a biosimilar recombinant G-CSF (Tevagrastim) has been approved for various indications similar to those of reference filgrastim, including stem cell mobilization for auto-HSCT; however, in the United States, tbo-filgrastim (Granix) is registered under the original biological application and is not approved for stem cell mobilization...
December 2017: Biology of Blood and Marrow Transplantation
https://www.readbyqxmd.com/read/28278727/biosimilars-of-filgrastim-in-autologous-stem-cell-transplantation-certain-differences-for-myeloma-patients-only
#10
Christophe Nicol, Chloé Henry, Marie-Anne Couturier, Pascal Delépine, Céline Tripogney, Caroline Buors, Gaëlle Guillerm, Christian Berthou, Adrian Tempescul, Jean-Christophe Ianotto
No abstract text is available yet for this article.
September 2017: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/28182150/evaluation-of-a-biosimilar-granulocyte-colony-stimulating-factor-filgrastim-xm02-for-peripheral-blood-stem-cell-mobilization-and-transplantation-a-single-center-experience-in-japan
#11
Hideaki Yoshimura, Masaaki Hotta, Takahisa Nakanishi, Shinya Fujita, Aya Nakaya, Atsushi Satake, Tomoki Ito, Kazuyoshi Ishii, Shosaku Nomura
BACKGROUND: Biosimilar granulocyte colony-stimulating factor (G-CSF) has recently been introduced into clinical practice. G-CSFs are used to mobilize CD34+ cells and accelerate engraftment after transplantation. However, in Asia, particularly in Japan, data for peripheral blood stem cell (PBSC) mobilization by this biosimilar G-CSF are currently lacking. Therefore, the clinical efficacy and safety of biosimilar G-CSF for hematopoietic stem cell transplantation needs to be evaluated in a Japanese context...
2017: Journal of Blood Medicine
https://www.readbyqxmd.com/read/28066881/short-acting-erythropoiesis-stimulating-agents-for-anaemia-in-predialysis-patients
#12
REVIEW
Deirdre Hahn, Christopher I Esezobor, Noha Elserafy, Angela C Webster, Elisabeth M Hodson
BACKGROUND: The benefits of erythropoiesis-stimulating agents (ESA) for chronic kidney disease (CKD) patients have been previously demonstrated. However, the efficacy and safety of short-acting epoetins administered at larger doses and reduced frequency as well as of new epoetins and biosimilars remains uncertain. OBJECTIVES: This review aimed to evaluate the benefits and harms of different routes, frequencies and doses of epoetins (epoetin alpha, epoetin beta and other short-acting epoetins) for anaemia in adults and children with CKD not receiving dialysis...
January 9, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/27623036/mexican-biosimilar-filgrastim-for-autologous-hematopoietic-stem-cell-mobilization-and-transplantation
#13
RANDOMIZED CONTROLLED TRIAL
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
#14
COMPARATIVE STUDY
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)...
December 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
#15
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
#16
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-IL2rγnull (NOG) and NOD/LtSz-scid IL2rγnull (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...
January 1, 2017: 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
#17
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
#18
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
#19
REVIEW
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
#20
COMPARATIVE STUDY
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®)...
February 2017: Journal of Clinical Apheresis
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