Scientific and legal viability of follow-on protein drugs

被引：37

作者：

Dudzinski, David M. ^{[1
]}

Kesselheim, Aaron S. ^{[2
]}

机构：

[1] Massachusetts Gen Hosp, Dept Med, Boston, MA 02114 USA

[2] Brigham & Womens Hosp, Div Pharmacoepidemiol & Pharmacoecon, Boston, MA 02115 USA

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2008年 / 358卷 / 08期

关键词：

D O I：

10.1056/NEJMhle0706973

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Many recombinant-protein drugs such as erythropoietin are now off patent, and the availability of generic versions of these drugs would reduce costs. The federal laws that simplify and expedite approval of generic forms of other drugs do not apply to recombinant-protein drugs. Congress is developing legislation to facilitate the approval of follow-on protein drugs. Copyright © 2008 Massachusetts Medical Society. All rights reserved.

引用

页码：843 / 849

页数：7

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