Gregory J Glover
Pharmaceutical Law Group PC, USA
Title: Regulatory market exclusivity issues for biologics and biosimilars
Biography
Biography: Gregory J Glover
Abstract
This presentation will describe the market exclusivity provisions that apply to biosimilars in the United States and the associated commercial implications of those provisions. The presentation will include a brief review of the market exclusivity provisions for small molecules (the Hatch-Waxman Act) and a comparison between the legal and regulatory structure for generic drugs and biosimilars.