title: Biosimilar G-CSF based mobilization of peripheral blood hematopoietic stem cells for autologous and allogeneic stem cell transplantation.
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.
authors: 1. University Clinic Heidelberg, Internal Medicine V (Hematology, Oncology and Rheumatology) University of Heidelberg, 69120 Heidelberg, Germany.
authors: Michael
authors: M
authors: Schmitt
authors: 2. University Hospital Southampton, Southampton, United Kingdom.
authors: Amy
authors: A
authors: Publicover
authors: 2. University Hospital Southampton, Southampton, United Kingdom.
authors: Kim H
authors: KH
authors: Orchard
authors: 3. Research Group Biomolecular NMR Spectroscopy, Leibniz Institute for Age Research - Fritz Lipmann Institute e.V. (FLI), Jena, Germany.
authors: Matthias
authors: M
authors: Görlach
authors: 1. University Clinic Heidelberg, Internal Medicine V (Hematology, Oncology and Rheumatology) University of Heidelberg, 69120 Heidelberg, Germany.
authors: Lei
authors: L
authors: Wang
authors: 1. University Clinic Heidelberg, Internal Medicine V (Hematology, Oncology and Rheumatology) University of Heidelberg, 69120 Heidelberg, Germany.
authors: Anita
authors: A
authors: Schmitt
authors: 1. University Clinic Heidelberg, Internal Medicine V (Hematology, Oncology and Rheumatology) University of Heidelberg, 69120 Heidelberg, Germany.
authors: Jiju
authors: J
authors: Mani
authors: 4. 2nd Department of Internal Medicine, Propaedeutic, Attikon General University Hospital, University of Athens, Greece.
authors: Panagiotis
authors: P
authors: Tsirigotis
authors: 1. University Clinic Heidelberg, Internal Medicine V (Hematology, Oncology and Rheumatology) University of Heidelberg, 69120 Heidelberg, Germany.
authors: Reeba
authors: R
authors: Kuriakose
authors: 5. Hematology Division, BMT and Cord Blood Bank, Tel-Aviv University, Chaim Sheba Medical Center, Tel-Hashomer, Israel.
authors: Arnon
authors: A
authors: Nagler
mesh_terms: D000595:Amino Acid Sequence; D059451:Biosimilar Pharmaceuticals / Q000737:chemistry / Q000627:therapeutic use*; D016179:Granulocyte Colony-Stimulating Factor / Q000737:chemistry / Q000627:therapeutic use*; D019650:Hematopoietic Stem Cell Mobilization / Q000379:methods*; D006801:Humans; D008969:Molecular Sequence Data; D033581:Stem Cell Transplantation / Q000379:methods*; D014182:Transplantation, Autologous / Q000379:methods; D014184:Transplantation, Homologous / Q000379:methods
chemical_list: D059451:Biosimilar Pharmaceuticals; D016179:Granulocyte Colony-Stimulating Factor
keywords: Biosimilar G-CSF; autologous & allogeneic transplantation; healthy donors; hematopoietic stem cells; mobilization