Open AccessThe quest for generic biotechnology pharmaceuticals in the USA
Author(s) -
Thomas J Kowalski,
Pamela Fekete,
Nne-Marie C Yvon
Publication year - 2005
Publication title -
journal of commercial biotechnology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.107
H-Index - 17
eISSN - 1478-565X
pISSN - 1462-8732
DOI - 10.5912/jcb126
Subject(s) - investor relations , microbiology and biotechnology , statutory law , government (linguistics) , business , bioethics , human growth hormone , pharmaceutical industry , growth hormone , marketing , strategic management , political science , biology , law , linguistics , philosophy , biochemistry , hormone
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.