Biosimilar G-CSF based mobilization of peripheral blood hematopoietic stem cells for autologous and allogeneic stem cell transplantation
Biosimilar G-CSF based mobilization of peripheral blood hematopoietic stem cells for autologous and allogeneic stem cell transplantation
The use of granulocyte colony stimulating factor (G-CSF) biosimilars for peripheral blood hematopoietic stem cell (PBSC) mobilization has stimulated an ongoing debate regarding their efficacy and safety. However, the use of biosimilar G-CSF was approved by the European Medicines Agency (EMA) for all the registered indications of the originator G-CSF (Neupogen (®) ) including mobilization of stem cells. Here, we performed a comprehensive review of published reports on the use of biosimilar G-CSF covering patients with hematological malignancies as well as healthy donors that underwent stem cell mobilization at multiple centers using site-specific non-randomized regimens with a biosimilar G-CSF in the autologous and allogeneic setting. A total of 904 patients mostly with hematological malignancies as well as healthy donors underwent successful autologous or allogeneic stem cell mobilization, respectively, using a biosimilar G-CSF (520 with Ratiograstim®/Tevagrastim, 384 with Zarzio®). The indication for stem cell mobilization in hematology patients included 326 patients with multiple myeloma, 273 with Non-Hodgkin's lymphoma (NHL), 79 with Hodgkin's lymphoma (HL), and other disease. 156 sibling or volunteer unrelated donors were mobilized using biosimilar G-CSF. Mobilization resulted in good mobilization of CD34+ stem cells with side effects similar to originator G-CSF. Post transplantation engraftment did not significantly differ from results previously documented with the originator G-CSF. The side effects experienced by the patients or donors mobilized by biosimilar G-CSF were minimal and were comparable to those of originator G-CSF. In summary, the efficacy of biosimilar G-CSFs in terms of PBSC yield as well as their toxicity profile are equivalent to historical data with the reference G-CSF.
Amino Acid Sequence, Biosimilar Pharmaceuticals, Granulocyte Colony-Stimulating Factor, Hematopoietic Stem Cell Mobilization, Humans, Molecular Sequence Data, Stem Cell Transplantation, Transplantation, Autologous, Transplantation, Homologous, Journal Article, Research Support, Non-U.S. Gov't, Review
280-289
Schmitt, Michael
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Publicover, Amy
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Orchard, Kim H
794654ab-d6cc-488a-ac11-c9217433c7a2
Görlach, Matthias
ca46f617-1b74-4059-bd1a-d4e43391db38
Wang, Lei
414e92d7-ec71-4a00-9487-757212d6f6f8
Schmitt, Anita
48672641-6dfc-4601-bf7f-d30367eb705a
Mani, Jiju
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Tsirigotis, Panagiotis
41e85047-9313-4c32-bb7d-fe3478af3038
Kuriakose, Reeba
af7ca335-248a-4f68-90dd-e23d62bc2204
Nagler, Arnon
6c8f642a-138e-4b6d-a22d-e59326f1a4a5
2014
Schmitt, Michael
17c42a41-f6f9-41a4-a2a0-1085adab2079
Publicover, Amy
0c2c45a4-c13b-4146-9130-f8549beb49ff
Orchard, Kim H
794654ab-d6cc-488a-ac11-c9217433c7a2
Görlach, Matthias
ca46f617-1b74-4059-bd1a-d4e43391db38
Wang, Lei
414e92d7-ec71-4a00-9487-757212d6f6f8
Schmitt, Anita
48672641-6dfc-4601-bf7f-d30367eb705a
Mani, Jiju
5e931196-f1c6-4a0c-ab66-f1f68038e10e
Tsirigotis, Panagiotis
41e85047-9313-4c32-bb7d-fe3478af3038
Kuriakose, Reeba
af7ca335-248a-4f68-90dd-e23d62bc2204
Nagler, Arnon
6c8f642a-138e-4b6d-a22d-e59326f1a4a5
Schmitt, Michael, Publicover, Amy, Orchard, Kim H, Görlach, Matthias, Wang, Lei, Schmitt, Anita, Mani, Jiju, Tsirigotis, Panagiotis, Kuriakose, Reeba and Nagler, Arnon
(2014)
Biosimilar G-CSF based mobilization of peripheral blood hematopoietic stem cells for autologous and allogeneic stem cell transplantation.
Theranostics, 4 (3), .
(doi:10.7150/thno.7752).
Abstract
The use of granulocyte colony stimulating factor (G-CSF) biosimilars for peripheral blood hematopoietic stem cell (PBSC) mobilization has stimulated an ongoing debate regarding their efficacy and safety. However, the use of biosimilar G-CSF was approved by the European Medicines Agency (EMA) for all the registered indications of the originator G-CSF (Neupogen (®) ) including mobilization of stem cells. Here, we performed a comprehensive review of published reports on the use of biosimilar G-CSF covering patients with hematological malignancies as well as healthy donors that underwent stem cell mobilization at multiple centers using site-specific non-randomized regimens with a biosimilar G-CSF in the autologous and allogeneic setting. A total of 904 patients mostly with hematological malignancies as well as healthy donors underwent successful autologous or allogeneic stem cell mobilization, respectively, using a biosimilar G-CSF (520 with Ratiograstim®/Tevagrastim, 384 with Zarzio®). The indication for stem cell mobilization in hematology patients included 326 patients with multiple myeloma, 273 with Non-Hodgkin's lymphoma (NHL), 79 with Hodgkin's lymphoma (HL), and other disease. 156 sibling or volunteer unrelated donors were mobilized using biosimilar G-CSF. Mobilization resulted in good mobilization of CD34+ stem cells with side effects similar to originator G-CSF. Post transplantation engraftment did not significantly differ from results previously documented with the originator G-CSF. The side effects experienced by the patients or donors mobilized by biosimilar G-CSF were minimal and were comparable to those of originator G-CSF. In summary, the efficacy of biosimilar G-CSFs in terms of PBSC yield as well as their toxicity profile are equivalent to historical data with the reference G-CSF.
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More information
Published date: 2014
Keywords:
Amino Acid Sequence, Biosimilar Pharmaceuticals, Granulocyte Colony-Stimulating Factor, Hematopoietic Stem Cell Mobilization, Humans, Molecular Sequence Data, Stem Cell Transplantation, Transplantation, Autologous, Transplantation, Homologous, Journal Article, Research Support, Non-U.S. Gov't, Review
Identifiers
Local EPrints ID: 413220
URI: http://eprints.soton.ac.uk/id/eprint/413220
ISSN: 1838-7640
PURE UUID: 6564ee62-877a-4074-8ae9-5f2420e1e63c
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Date deposited: 17 Aug 2017 16:30
Last modified: 16 Mar 2024 03:26
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Author:
Michael Schmitt
Author:
Amy Publicover
Author:
Kim H Orchard
Author:
Matthias Görlach
Author:
Lei Wang
Author:
Anita Schmitt
Author:
Jiju Mani
Author:
Panagiotis Tsirigotis
Author:
Reeba Kuriakose
Author:
Arnon Nagler
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