Totality of the evidence at work: The first US biosimilar

被引：34
|
作者：
Holzmann, J. [1 ]
Balser, S. [2 ]
Windisch, J. [1 ]
机构：
[1] Sandoz Biopharmaceut, Biopharmaceut Dev, A-6250 Kundl, Austria
[2] HEXAL AG, Clin Dev Biopharmaceut, Oberhaching, Germany
来源：
EXPERT OPINION ON BIOLOGICAL THERAPY | 2016年 / 16卷 / 02期
关键词：
Biosimilar; filgrastim; filgrastim-sndz; G-CSF; Neupogen; neutropenia; Zarxio; FILGRASTIM; CHEMOTHERAPY; NEUTROPENIA;
D O I：
10.1517/14712598.2016.1128410
中图分类号：
Q81 [生物工程学（生物技术）]; Q93 [微生物学];
学科分类号：
071005 ; 0836 ; 090102 ; 100705 ;
摘要：
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.
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收藏
页码：137 / 142
页数：6
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