Regulatory market exclusivity issues for biologics and biosimilars

4^th International Conference and Exhibition on Biologics & Biosimilars

October 26-28, 2015 Baltimore, USA

Gregory J Glover

Pharmaceutical Law Group PC, USA

Posters-Accepted Abstracts: J Bioanal Biomed

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-0Waxman Act) and a comparison between the legal and regulatory structure for generic drugs and biosimilars.

Biography :

Email: Gregory.Glover@pharmalawgrp.com