Five Proposals to Stop the Games and Encourage a Robust Biosimilar Market

FDA Request for Comments on Biologics Marketplace, 2018

1 Pages Posted: 12 Oct 2018

Date Written: September 14, 2018

Abstract

This short comment offers five proposals that could encourage a more robust market for biosimilars, targeting REMS denials, non-REMS denials, citizen petitions, and disparagement, and discussing coordination with the FTC.

Keywords: FDA, competition, antitrust, REMS, citizen petitions, FTC

JEL Classification: I18, K21, L40, L41, L43, L65, O34, O38

Suggested Citation

Carrier, Michael A., Five Proposals to Stop the Games and Encourage a Robust Biosimilar Market (September 14, 2018). FDA Request for Comments on Biologics Marketplace, 2018. Available at SSRN: https://ssrn.com/abstract=3251528

Michael A. Carrier (Contact Author)

Rutgers Law School ( email )

217 North Fifth Street
Camden, NJ 08102-1203
United States
856-225-6380 (Phone)
856-225-6516 (Fax)

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