Thomas J Kowalski
Pamela Fekete
nne-Marie C Yvon



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.

Keywords:generic biologics ,biogenerics ,biotechnological pharmaceuticals ,follow-on biologics ,en ,