How to select a biosimilar

被引：14

作者：

Boone, Niels ^{[1
]}

van der Kuy, Hugo ^{[1
]}

Scott, Mike ^{[2
]}

Mairs, Jill ^{[2
]}

Kraemer, Irene ^{[3
]}

Vulto, Arnold ^{[4
]}

Janknegt, Rob ^{[1
]}

机构：

[1] Orbis Med Ctr, Dept Clin Pharm & Toxicol, NL-6130 MB Sittard Geleen, Netherlands

[2] Antrim Area Hosp, Dept Clin Pharm, Belfast, Antrim, North Ireland

[3] Johannes Gutenberg Univ Mainz, Univ Med Ctr, D-55122 Mainz, Germany

[4] Erasmus MC, Dept Clin Pharm & Toxicol, Rotterdam, Netherlands

来源：

EUROPEAN JOURNAL OF HOSPITAL PHARMACY-SCIENCE AND PRACTICE | 2013年 / 20卷 / 05期

关键词：

THERAPEUTIC PROTEINS; IMMUNOGENICITY; IMPACT; TOOL;

D O I：

10.1136/ejhpharm-2013-000370

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

In the past few years biosimilars have penetrated the market following the expiry of patents of originator variants. This offers the opportunity to apply high-tech protein products at a lower cost. In contrast to small-molecule generics, clinicians and pharmacists have found it difficult to judge the efficacy and safety profiles of complex protein products. In recent years, the European Medicines Agency (EMA) has gained knowledge on assessing comparability between biosimilars and originator products in scientific and legal areas. This article provides an overview of an extensive set of 31 previously drawn biosimilar selection criteria and describes how several of these criteria are covered by EMA regulations and guidelines. A panel of experts (authors) reviewed the criteria and produced a shortlist of 10 criteria relevant for clinicians and pharmacists.

引用

页码：275 / 286

页数：12

共 47 条

[11]

European Generic Medicines Association, 2011, BIOS HDB, P29

[12]

European Medicines Agency, 2011, EMEACHMPEWP192217200

[13]

European Medicines Agency, 2009, RAT EPAR SCI DISC

[14]

European Medicines Agency, 2012, EMACHMPBMWP403543201

[15]

European Medicines Agency, 2012, EMA1213402011

[16]

European Medicines Agency, 2011, EMA41001

[17]

European Medicines Agency, 2009, FILGR HEX EPAR PUBL

[18]

European Medicines Agency, 2013, EMA9404512011

[19]

European Medicines Agency, 2010, NIV EPAR PUBL ASS RE

[20]

European Medicines Agency, PROC STEPS TAK SCI I

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