Follow-On Biologics: Intellectual Property and Innovation Issues

Abstract

Biologics, which are sometimes termed biopharmaceuticals or biotechnology drugs, have begun to play an increasingly important role in U.S. health care. Not only are sales of biologics growing rapidly, some experts estimate that in coming years half of all newly approved drugs will result from biotechnology. This report contains information on marketing approval issues, intellectual property issues, and innovation issues as related to biologics.