Biosimilars: Extrapolation for oncology

被引：32

作者：

Curigliano, Giuseppe ^{[1
]}

O'Connor, Darran P. ^{[2
]}

Rosenberg, Julie A. ^{[3
]}

Jacobs, Ira ^{[4
]}

机构：

[1] European Inst Oncol, Div Expt Therapeut, Milan, Italy

[2] Royal Coll Surgeons Ireland, Dept Mol & Cellular Therapeut, 123 St Stephens Green, Dublin 2, Ireland

[3] Pfizer Inc, Groton, CT 06340 USA

[4] Pfizer Inc, 235 East 42nd St, New York, NY 10017 USA

来源：

CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY | 2016年 / 104卷

关键词：

Cancer; Extrapolation; Biosimilar; Monoclonal antibody; STEM-CELLS; G-CSF; MOBILIZATION;

D O I：

10.1016/j.critrevonc.2016.06.002

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

A biosimilar is a biologic that is highly similar to a licensed biologic (the reference product) in terms of purity, safety and efficacy. If the reference product is licensed to treat multiple therapeutic indications, extrapolation of indications, i.e., approval of a biosimilar for use in an indication held by the reference product but not directly studied in a comparative clinical trial with the biosimilar, may be possible but has to be scientifically justified. Here, we describe the data required to establish biosimilarity and emphasize that indication extrapolation is based on scientific principles and known mechanism of action. (C) 2016 The Authors and Pfizer Inc. Published by Elsevier Ireland Ltd.

引用

页码：131 / 137

页数：7

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