Generic Versions of Biologics: The Problem and a Possible Solution

  • Paul F. Prestia
  • Published 2008

Abstract

In 1984, Congress transformed the U.S. drug industry with the Hatch-Waxman Act. From that act, the generic drug industry and generic drugs evolved, ultimately saving consumers tens, if not hundreds, or billions of dollars. Nascent generic drug companies received a clear pathway to make and market generic drugs and traditional pharmaceutical companies received the promise of shortterm market exclusivity and long-term extended patent protection. By most standards, the tradeoff has worked well and relatively little legislative tinkering has been required since 1984.

Cite this paper

@inproceedings{Prestia2008GenericVO, title={Generic Versions of Biologics: The Problem and a Possible Solution}, author={Paul F. Prestia}, year={2008} }