The US Biosimilar Market: Progress, Challenges, and Possible Reforms | Feb. 3

| January 21, 2021
Submitted by Yuxuan Jiang for Medical Law Intereset Group, Michael G DeGroote School of Medicine

The Medical Law Interest Group at the School of Medicine is pleased to invite our business colleagues to a guest lecture by Dr. Ameet Sarpatwari, JD, PhD, Assistant Professor of Harvard Medical School and Associate Epidemiologist at the Bridgham and Woman’s Hospital, on the topic of “US Biosimilar Market: Progress, Challenges, and Possible Reforms.”

In 2010, Congress passed the Biologics Price Competition and Innovation Act (BPCIA) to address high biologic prices by creating an abbreviated approval pathway for other manufacturers to start selling their own versions of originator biologics called biosimilars. However, over a decade later, the BPCIA has not yet led to vigorous price competition from biosimilars. This talk examines the role that FDA regulatory policy, patent litigation, and market dynamics have played in this stunted growth while highlighting emerging signs of progress and possible reforms to make the US biosimilars market more vibrant.

Event details: 

Speaker Biography:

Ameet Sarpatwari, JD, PhD is an Assistant Professor of Medicine at Harvard Medical School, an Associate Epidemiologist at Brigham and Women’s Hospital, and Assistant Director of the Program On Regulation, Therapeutics, And Law (PORTAL) within the Division of Pharmacoepidemiology and Pharmacoeconomics. His research draws upon his interdisciplinary training as an epidemiologist and lawyer and focuses on the effects of laws and regulations on therapeutic development, approval, use, and related public health outcomes.

Dr. Sarpatwari completed his undergraduate studies at the University of Virginia, studied epidemiology at the University of Cambridge, and studied law at the University of Maryland.

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