Totality of the evidence at work: The first U.S. biosimilar

On March 6(th) 2015, the Food and Drug Administration (FDA) approved filgrastim-sndz (Zarxio) as the first biosimilar in the United States (US) for all indications of the reference product. Filgrastim-sndz is a biosimilar of Amgen's Neupogen and is mainly used to treat neutropenia in cancer patients receiving chemotherapy. This article presents a summary of the analytical and clinical studies submitted by Sandoz and describes how the information was integrated to provide the 'totality of the evidence' leading to the approval of the biosimilar.