Potential Savings of Biogenerics in the United States

Abstract

Unlike other prescription medications, biologic medications are available only in brand form - i.e., from the original patent holder at higher cost. Currently, no pathway to generic approval is available for these drugs. This study calculated the potential savings to the U.S. health care system that could be realized if the Food and Drug Administration were to develop a pathway for evaluation and approval of generic biologic medications or biogenerics.