Biosimilar G-CSF safe for mobilization of stem cells

The European Medicines Agency (EMA) approved biosimilar G-CSF (Biograstim, Nivestim, Ratiograstim, Tevagrastim, Zarzio) in 2008–2009 for the same indications as the originator biological Neupogen (filgrastim) [2]. These indications include chemotherapy induced neutropenia (CIN), agranulocytosis and neutropenia due to infection with the human immunodeficiency virus (HIV) and mobilization of stem cells in the autologous and allogeneic settings.

Filgrastim is a growth factor used to aid the recovery of bone marrow after chemotherapy treatment for cancer. Especially in patients with neutropenia (low white blood cell count in the blood), which causes reduced immune response. It may also be used to mobilize CD34+ stem cells in healthy donors; however, there is limited experience on the use of biosimilar G-CSF for the mobilization of PBSCs especially in healthy donors [3].

A group of researchers specialised in haematology, oncology and rheumatology carried out a comprehensive review of published reports on the use of biosimilar G-CSF covering patients with haematological malignancies as well as healthy donors that underwent stem cell mobilization at multiple centres using site-specific non-randomized regimens with a biosimilar G-CSF in the autologous and allogeneic setting.

The study included 748 patients (mostly with haematological malignancies) and 156 healthy donors who underwent successful autologous or allogeneic stem cell mobilization, respectively, using a biosimilar G-CSF (520 Ratiograstim/Tevagrastim, 384 Zarzio).

The data from the 904 individuals showed that use of biosimilar G-CSF resulted in good mobilization of CD34+ stem cells with side effects similar to originator G-CSF. No significant differences were also found between biosimilar G-CSF and Neupogen for the key parameters measured for PBSCs harvest and for post-transplantation engraftment. The side effects experienced by the patients or donors mobilized by biosimilar G-CSF were minimal and comparable to those of originator G-CSF.

There is an increasing body of data summarizing the experience of using biosimilar G-CSF in patients with chemotherapy induced neutropenia and for the mobilization of autologous PBSC, which includes pharmacovigilance data for Ratiograstim/Tevagrastim on more than 100,000 patients. This data, the authors conclude, shows that biosimilar G-CSF is ‘as safe and effective in PBSC mobilization as the originator G-CSF’.

Conflict of interest
The authors of the research paper [1] reported the following conflicts of interest:

A Schmitt, M Schmitt, A Publicover, KH Orchard and A Nagler received travel grants. A Nagler, KH Orchard and M Schmitt received research grants and speaker’s honoraria from Teva. M Görlach received speaker’s and consultant’s honoraria from Teva. A Publicover received an unrestricted educational grant from Teva. M Schmitt received speaker’s honoraria from Amgen. J Mani, L Wang, P Tsirigotis and R Kuriakose declared no conflict of interest.

Editor’s comment
Readers interested to learn more about the safety and toxicity of biosimilars are invited to view the following manuscript published in GaBI Journal:

Safety and toxicity of biosimilars—EU versus US regulation

If you are interested in contributing a research paper in a similar area to the GaBI Journal, please send us your submission here.

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Use of G-CSF biosimilars for stem cell mobilization in healthy donors

Pharmacodynamic response of biosimilar filgrastim

References
1.   Schmitt M, et al. Biosimilar G-CSF based mobilization of peripheral blood hematopoietic stem cells for autologous and allogeneic stem cell transplantation. Theranostics. 2014;4(3):280-9.
2.   GaBI Online – Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 May 2]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3.   GaBI Online – Generics and Biosimilars Initiative. Mobilization of stem cells in healthy donors by G-CSF biosimilars shows comparable efficacy and safety to Neupogen [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 May 2]. Available from:www.gabionline.net/Biosimilars/Research/Mobilization-of-stem-cells-in-healthy-donors-by-G-CSF-biosimilars-shows-comparable-efficacy-and-safety-to-Neupogen

Source: www.gabionline.net