文章基本信息

标题：The quest for generic biotechnology pharmaceuticals in the USA
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作者：Thomas J Kowalski ; Pamela Fekete ; nne-Marie C Yvon 等
期刊名称：Journal of Commercial Biotechnology
印刷版ISSN：1478-565X
出版年度：2005
卷号：11
期号：3
DOI：10.5912/jcb126
语种：English
出版社：thinkBiotech LLC
摘要：As patent protection expires on the first generation of biotechnology products, such as human growth hormone and erythropoietin, there is an impetus for the development and marketing of generic equivalents. Currently there is no statutory or regulatory framework governing generic biotechnology products. This paper explores the potential solutions that have been suggested by members of the pharmaceutical industry and government, both in the USA and internationally.
关键词：generic biologics;biogenerics;biotechnological pharmaceuticals;follow-on biologics