Mobilization of hematopoietic progenitor cells from allogeneic healthy donors using a new biosimilar G‐CSF (Zarzio®)

Abstract

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®. Donor characteristics were equivalent between groups, and no severe adverse effects were registered in the Zarzio® group. The number of CD34 cells collected/Kg recipient body weight was 6.7 × 10(6) (3.8-11.1) in the Zarzio® group versus 8.4 × 10(6) (5.6-16.6) in the Neupogen® group (P = 0.04). We collected the minimal target cell dose (2 × 10(6) /kg) in all donors from each group and no significant differences were found in the collection of the optimal cell dose (5 × 10(6) /kg) between groups, although 3/18 (16.6%) donors that received Zarzio® failed to mobilize the optimal cell dose compared with 0% in the Neupogen® group. A total of 35 patients proceeded to transplantation (17 in the Zarzio® and 18 in the Neupogen® groups, respectively). Platelet and neutrophil median time to engraftment was comparable between the two groups. Our retrospective study supports the conclusion that Zarzio® mobilization of PBPCs in healthy donors is safe but perhaps not as effective as the reference Neupogen. However, more prospective trials are required to definitively asses the safety and efficacy of G-CSF biosimilars for PBPCs mobilization in healthy donors.

Efficacy of three filgrastim‐intended copies for hematopoietic stem cell mobilization in healthy adult and pediatric donors in Mexico

“…Most studies on biosimilar use in HSCT have been focused on autologous transplantation, where experience has been largely positive . On the other hand, the use of biosimilar G‐CSFs for stem cell mobilization in healthy donors was initially met with less enthusiasm although evidence on their safety and efficacy is accumulating . Results from a large retrospective study reported similar findings to ours using the biosimilar G‐CSF Zarzio (Sandoz, Germany) in n = 85 donors compared with patients who received Neupogen and lenograstim, without observing a difference in the number of CD34+ cells collected in the first apheresis session and a 93% first‐apheresis success rate, similar to patients who received the originator and superior to lenograstim .…”

Mobilization of autologous and allogeneic peripheral blood stem cells for transplantation in haematological malignancies using biosimilar G‐CSF

“…We performed a comprehensive review of published reports of both patients and healthy donors who underwent stem cell mobilization with biosimilar G‐CSF. The database pubmed.org and the abstract books of the Annual Meetings of the European Society for Blood and Marrow Transplantation (EBMT), the European Hematology Association (EHA) and the American Society of Hematology (ASH) in 2012, 2013, 2014 and 2015 were reviewed for peer‐reviewed papers and peer‐reviewed abstracts, respectively, regarding the mobilization of stem cells with a biosimilar G‐CSF .…”

Extrapolation in Practice: Lessons from 10 Years with Biosimilar Filgrastim

“…Importantly, although most data in stem cell mobilization are in the autologous setting, evidence is also emerging in allogeneic stem cell mobilization. A recent systematic review discussed the evidence for biosimilar filgrastim in the allogeneic setting, including 331 patients in eight studies [33, 45–50]. This included real-world evidence, including data from the largest healthy volunteer donor cohort ( n = 244) of allogeneic stem cell mobilization reported to date [51], a long-term ongoing safety surveillance study with a planned duration of 10 years.…”