In support of the European Union biosimilar framework

被引：30

作者：

Schneider, Christian K. ^{[1
,2
]}

Borg, John J. ^{[3
]}

Ehmann, Falk ^{[4
]}

Ekman, Niklas ^{[5
]}

Heinonen, Esa ^{[5
,6
]}

Ho, Kowid ^{[7
]}

Hoefnagel, Marcel H. ^{[8
]}

van der Plas, Roeland Martijn ^{[8
]}

Ruiz, Sol ^{[9
]}

van der Stappen, Antonius J. ^{[8
]}

Thorpe, Robin

Tiitso, Klara ^{[4
]}

Tsiftsoglou, Asterios S. ^{[10
]}

Vleminckx, Camille ^{[4
]}

Waxenecker, Guenter ^{[11
]}

Welin, Mats ^{[12
]}

Weise, Martina ^{[13
]}

Trouvin, Jean-Hugues ^{[7
,14
]}

机构：

[1] Danish Hlth & Med Author, Copenhagen, Denmark

[2] Twincore Ctr Expt & Clin Infect Res, Hannover, Germany

[3] Med Author, Gzira, Malta

[4] EMA, London, England

[5] Finnish Med Agcy FIMEA, Helsinki, Finland

[6] Swissmedic, Bern, Switzerland

[7] Agence Natl Securite Medicament & Prod Sante ANSM, Paris, France

[8] Med Evaluat Board CBG MEB, Utrecht, Netherlands

[9] Spanish Med Agcy AEMPS, Madrid, Spain

[10] Aristotle Univ Thessaloniki, GR-54006 Thessaloniki, Greece

[11] Austrian Med & Med Devices Agcy AGES, Vienna, Austria

[12] MPA, Uppsala, Sweden

[13] Bundesinst Arzneimittel & Med Prod BfArM, Bonn, Germany

[14] Univ Paris 05, Paris, France

来源：

NATURE BIOTECHNOLOGY | 2012年 / 30卷 / 08期

关键词：

D O I：

10.1038/nbt.2322

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：

引用

页码：745 / 748

页数：4

共 16 条

[1]

[Anonymous], EMACHMPBMWP652000201

[2]

[Anonymous], EMEACHMPBMWP30163620

[3]

[Anonymous], 2012, EMA

[4]

European Medicines Agency, 2006, EMEACHMPBMWP31329200

[5]

European Medicines Agency, 2006, CHMPBWP4934805 EUR M

[6]

European Medicines Agency, 2012, MULT GUID BIOS

[7]

European Medicines Agency, 2009, EMEACHMPBMWP63261320

[8]

European Medicines Agency, 2012, EMACHMPBWP2477132012

[9]

European Medicines Agency, 2011, EMACHMPBMWP572828201

[10]

European Medicines Agency, 2009, EMEACHMPBMWP11826420

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