Request for Comments and Announcement of Public Workshop Follow-On Biologics: Impact of Recent Legislative and Regulatory Naming Proposals on Competition #00034

Submission Number:
00034
Commenter:
Joanna Shepherd
Organization:
Emory University School of Law
State:
Georgia
Initiative Name:
Request for Comments and Announcement of Public Workshop Follow-On Biologics: Impact of Recent Legislative and Regulatory Naming Proposals on Competition
Matter Number:

P131208

Attached is my forthcoming article, "Biologic Drugs, Biosimilars, and Barriers to Entry". This Article explores the current conflict between biologic and biosimilar medications, and explains many of the critical issues discussed during the FTC Follow-on-Biologics Workshop. Using the principles of economic theory, evidence from other drug markets, the determinations of the FTC, and conclusions from empirical studies, the Article analyzes the consequences of entry barriers to biosimilars. Thank you