All three agents have similar safety profiles. None were statistically higher on safety parameters to what is known about originator filgrastim (Neupogen). What is known about filgrastim in general regarding safety can be extended to biosimilar filgrastim. Safety profiles may become more differentiated once long-term product-specific safety data are available. Large-sample, long-term, observational studies of real-world practice will provide the heterogeneity and statistical power to demonstrate product-specific safety profiles. Current evidence indicates that statistically no one product is less and no one product is more safe.

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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 ® in chemotherapy-treated cancer patients relative to the originator product filgrastim (Neupogen ® ). Source documents include: publicly available documents of the European Medicines Agency; a published article reviewing the (preapproval) clinical development of EP2006 (Zarzio ® ); and published (postapproval) single-center experience reports on prophylaxis with Zarzio ® , 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 ® are likely to be similar to those of Neupogen ® . Thus, Zarzio ® and Neupogen ® may be assumed interchangeable.