In the pharmaceutical industry, innovation is vital to bring more life-saving treatment options to patients. However, pharmaceutical manufacturers face strict safety and effectiveness guidelines set forth by the U.S. Food and Drug Administration (FDA), before being able to place their innovations on the market. In attempts to balance the need for continuous innovation and stringent regulation, policymakers created the Biologics Price Competition and Innovation Act (BPCIA) of 2009. The BPCIA allows biosimilars manufacturers to enter a shortened FDA approval pathway and provides incentives for biologics manufacturers with the aims to decrease cost and increase access to medications for patients by stimulating innovation within the industry. In this thesis, I empirically investigate the impact of the BPCIA on biopharmaceutical innovation. I utilize public data from the FDA and United States Patent and Trademark Office (USPTO) to measure these innovations and conduct regression analyses to estimate the effects of the BPCIA on related drug and patent approvals. My analysis shows that since its enactment, the BPCIA has increased innovation in biopharmaceuticals. Based on my results, I discuss implications for policymakers and future researchers.

Library of Congress Subject Headings

United States. Biologics Price Competition and Innovation Act of 2009; Biologicals; Drug development--Government policy--United States; Drug development--Technological innovations

Publication Date


Document Type


Student Type


Degree Name

Science, Technology and Public Policy (MS)

Department, Program, or Center

Public Policy (CLA)


Qing Miao

Advisor/Committee Member

Eric Hittinger

Advisor/Committee Member

Suzanne O'Handley


RIT – Main Campus

Plan Codes