Ensuring Expeditious Entry: Korea and the U.S. Regulatory Pathway for Bringing Biosimilars to Market

Abstract

Biosimilar products are expected to encounter substantial barriers in their efforts to compete with branded biologics. Current biosimilar regulatory regimes in both Korea and the U.S. raise questions about the viability of successfully bringing competition, innovation, and affordability into the biological products market as intended. Thus, bringing a biologic to market presents significant challenges that necessitate complex situations and subsequent legal regimes. This article will discuss the bilateral implications of each respective biosimilar regulatory pathway and the procedures each regime uses to resolve patent disputes. In particular, key amendments in pharmaceutical intellectual property provisions pursuant to the Korea-U.S. Free Trade Agreement suggest that select bilateral regulatory principles can enhance biosimilar market involvement. As a corollary, Korea's first invalidation action and several related cases in the U.S. in which courts interpreted some of the important provisions of the Korean Pharmaceutical Affairs Act and the Biologics Price Competition and Innovation Act of 2009 are analyzed using a comparative approach. Finally, future developments and exogenous factors that may impact the expeditious entry of the future first biosimilars into the two countries are applied to these legal regimes.