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Gregory J Glover

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.