Use of a biosimilar granulocyte colony‐stimulating factor for peripheral blood stem cell mobilization: an analysis of mobilization and engraftment

Abstract

Summary Peripheral blood haematopoietic progenitor cell mobilization has become a standard procedure prior to autologous stem cell transplantation. Biosimilar granulocyte colony‐stimulating factors (GCSF) have recently been awarded European Union (EU) licences for stem cell mobilization but data for their use in this context remain limited. The biosimilar GCSF, Ratiograstim® (Ratiopharm, Ulm, Germany) was granted an EU licence in September 2008 and incorporated into clinical practice in the Wessex Blood and Marrow Transplantation Programme in December 2008. Data were retrospectively collected for 154 consecutive patients undergoing peripheral blood stem cell harvest between January 2009 and December 2011 using the biosimilar GCSF. 131 consecutive patients from the preceding 3 years, who had received Neupogen®, were used as a control. We analysed both parameters relevant to stem cell collection and engraftment data, where patients proceeded to transplantation. We found no statistically significant difference between the two groups when comparing CD34 predictors, total number of CD34+ stem cells collected, number of days required for collection, or for time to engraftment. This is, to our knowledge, the largest direct comparison of a biosimilar GCSF with originator GCSF for stem cell mobilization. The use of biosimilar GCSF can produce a significant cost saving, allowing investment in other areas of stem cell transplantation.

Biosimilar G-CSF Based Mobilization of Peripheral Blood Hematopoietic Stem Cells for Autologous and Allogeneic Stem Cell Transplantation

“…An extensive literature review18-39 produced 904 patients mostly with hematological malignancies as well as healthy donors that underwent successful autologous or allogeneic stem cell mobilization respectively using a biosimilar G-CSF (Ratiograstim®/Tevagrastim® or Zarzio®). A total of 520 patients or donors underwent stem cell mobilization with Ratiograstim®/Tevagrastim®, while 384 patients or donors underwent stem cell mobilization with Zarzio®.…”

“…Use of a biosimilar G-CSF has significant cost advantages for a transplant unit 18. When first introduced in 2008, biosimilars were approximately 15% cheaper than the originator.…”

Update on biosimilars of granulocyte colony-stimulating factor – when no news is good news

“…Consequently, less restrictive prescribing could be encouraged, and thus patient access to these costly but highly effective drugs improved [31,32]. Indeed, since the advent of biosimilars the price of first-generation G-CSF has dropped by as much as 80% [3,29,30,33], that is, much more than the 25-30% which had been predicted. The six or so biosimilar G-CSF products licensed in Europe together now outsell the originator [28,34].…”

A dimeric peptide with erythropoiesis-stimulating activity uniquely affects erythropoietin receptor ligation and cell surface expression

“…As one example, rHu-GSF (and recently developed biosimilars) can be produced in bacterial systems, purified with recovery of high in vivo activity, and used with excellent success to treat neutropenia and to mobilize bone marrow CD34 pos progenitor cells for transplantation (Aapro, et al 2011, Publicover, et al 2013, Welte 2014). Other HGFs, in contrast, have been substantially more challenging to develop including Thrombopoietin (TPO) and Erythropoietin (EPO).…”