Biologic Drugs, Biosimilars, and Barriers to Entry
By Joanna Shepherd, Ph.D., Emory University School of Law
Health Matrix: Journal of Law-Medicine (forthcoming)
Congress has recently created a biosimilars approval pathway that would allow less expensive versions of biologic drugs to reach patients more quickly. However, original biologics manufacturers have sought to extend their monopoly profits by erecting various legal and regulatory barriers to entry. This paper discusses the various barriers and explores their market consequences.
Two of the largest pharmacy players in the U.S. — Express Scripts and Walgreens — have each recently released their latest specialty drug trends reports. Express Scripts shares new insights into why patients are non-adherent to their prescriptions and how to address this problem. This report also addresses the issue of pharmacy waste.