Global Regulatory Standards for the Approval of Biosimilars

被引：0
|
作者：
Mounho, Barbara [1 ]
Phillips, Audrey [2 ]
Holcombe, Kay [3 ]
Grampp, Gustavo [1 ]
Lubiniecki, Tony [4 ]
Mollerup, Inger [5 ]
Jones, Carolyn [6 ]
机构：
[1] Amgen Inc, Regulatory Affairs, Thousand Oaks, CA 91320 USA
[2] Johnson & Johnson, Biopharmaceut Publ Policy & Advocacy, New Brunswick, NJ USA
[3] Genzyme Corp, Cambridge, MA USA
[4] Johnson & Johnson, CMC Strategy Large Mol Portfolio Management, New Brunswick, NJ USA
[5] Novo Nordisk AS, Bagsvaerd, Denmark
[6] Biogen Idec Inc, Regulatory Policy, Weston, MA USA
来源：
FOOD AND DRUG LAW JOURNAL | 2010年 / 65卷 / 04期
关键词：
D O I：
暂无
中图分类号：
TS2 [食品工业];
学科分类号：
0832 ;
摘要：
引用
收藏
页码：819 / 837
页数：19
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