1. University Clinic Heidelberg, Internal Medicine V (Hematology, Oncology and Rheumatology) University of Heidelberg, 69120 Heidelberg, Germany.
2. University Hospital Southampton, Southampton, United Kingdom.
3. Research Group Biomolecular NMR Spectroscopy, Leibniz Institute for Age Research - Fritz Lipmann Institute e.V. (FLI), Jena, Germany
4. 2nd Department of Internal Medicine, Propaedeutic, Attikon General University Hospital, University of Athens, Greece.
5. Hematology Division, BMT and Cord Blood Bank, Tel-Aviv University, Chaim Sheba Medical Center, Tel-Hashomer, Israel.
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.
Keywords: Biosimilar G-CSF, hematopoietic stem cells, mobilization, autologous & allogeneic transplantation, healthy donors