title: Totality of the evidence at work: The first U.S. biosimilar.
abstract: 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.
authors.affiliation: a Sandoz Biopharmaceuticals , Biopharmaceuticals Development , Kundl , Austria.
authors.forename: J
authors.initials: J
authors.lastname: Holzmann
authors.affiliation: b HEXAL AG , Clinical Development Biopharmaceuticals , Oberhaching , Germany.
authors.forename: S
authors.initials: S
authors.lastname: Balser
authors.affiliation: a Sandoz Biopharmaceuticals , Biopharmaceuticals Development , Kundl , Austria.
authors.forename: J
authors.initials: J
authors.lastname: Windisch
mesh_terms: D000818:Animals; D059451:Biosimilar Pharmaceuticals / Q000493:pharmacokinetics / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000379:methods; D000069585:Filgrastim / Q000493:pharmacokinetics / Q000627:therapeutic use*; D006401:Hematologic Agents / Q000493:pharmacokinetics / Q000627:therapeutic use*; D006801:Humans; D009503:Neutropenia / Q000188:drug therapy* / Q000453:epidemiology; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
chemical_list: D059451:Biosimilar Pharmaceuticals; D006401:Hematologic Agents; D000069585:Filgrastim
keywords: Biosimilar; G-CSF; Neupogen; Zarxio; filgrastim; filgrastim-sndz; neutropenia