Clinical efficacy and safety of Zarzio® (EP2006), a biosimilar recombinant human granulocyte colony-stimulating factor

Abstract

This second review of biosimilar granulocyte colony-stimulating factors approved by the European Medicines Agency evaluates the evidence on the clinical efficacy and safety of prophylaxis of (febrile) neutropenia with Zarzio® to the originator product filgrastim (Neupogen® in chemotherapy-treated cancer patients relative). Source documents include: publicly available documents of the European Medicines Agency; a published article reviewing the (preapproval) clinical development of EP2006 (Zarzio® reports on prophylaxis with Zarzio®); and published (postapproval) single-center experience, including two reports in the cancer setting and one in the setting of autologous peripheral blood stem cell mobilization. Also included is: a pooled analysis of these and other postapproval studies in the cancer setting that includes (interim) data from the two single cancer center reports; one additional single-center experience study; one completed study; and one ongoing multicenter postapproval study. Based on the available therapeutic equivalence and safety data, the clinical and safety outcomes of Zarzio® to those of Neupogen® are likely to be similar. Thus, Zarzio® and Neupogen® may be assumed interchangeable.