Emerging Competition Issues Involving Follow-On Biologics

Abstract

In 2010, President Obama signed into law the Biologics Price Competition and Innovation Act, which created an abbreviated approval pathway for competing versions of previously-approved biologics. Passage of this legislation and the impending introduction of follow-on biologics, or biosimilars, into the marketplace raise the question of whether biologic product manufacturers will have to contend with the same antitrust scrutiny of their intellectual property litigation settlement agreements, life cycle management, and marketing practices that pharmaceutical drug firms have faced. In this article, we examine four ways in which pharmaceutical firms have allegedly delayed product entry in violation of the antitrust laws — reverse-payment settlements, REMS-based distribution restrictions, false Orange Book listings, and product hopping — and examine whether this conduct is likely to occur in the context of biologics and how the antitrust analysis of this conduct may differ for biologics.

Keywords: biologic, biosimilar, follow-on biologic, FOB, BPCIA, antitrust, competition, FTC, FDA

JEL Classification: I18, K21, K23, L40, L41, L42, L43, L44, L49