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

Authors Tharmarajah S, Mohammed A, Bagalagel A, MacDonald K, Abraham I

Received 12 December 2013

Accepted for publication 1 February 2014

Published 12 March 2014 Volume 2014:4 Pages 1—9

DOI https://doi.org/10.2147/BS.S28710

Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 4


Soba Tharmarajah,1,2 Abdulaziz Mohammed,3,4 Alaa Bagalagel,3,4 Karen MacDonald,2 Ivo Abraham2,3,5

1College of Pharmacy, University of Arizona, Tucson, AZ, USA; 2Matrix45, Tucson, AZ, USA; 3Center for Health Outcomes and PharmacoEconomic Research, College of Pharmacy, University of Arizona, Tucson, AZ, USA; 4College of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia; 5Department of Pharmacy Practice and Science, College of Pharmacy, University of Arizona, Tucson, AZ, USA

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® 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.

Keywords: biosimilars, biosimilar pharmaceuticals, efficacy, safety, granulocyte colony stimulating factor, recombinant proteins

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