Biologics and Biosimilars

Biography

Biography: George Yu

Abstract

The biosimilars market is expected to range from $2-20 billion or more by 2020. Yet, six years since the enactment of the Biologics Price Competition and Innovation Act (BPCIA), we are only on the cusp of the launch of the first biosimilar in the U.S., Sandoz’s Zarxio™ (filgrastim). However, the development of Zarxio™ has come with significant litigation already, particularly the fractured decision of the Court of Appeals for the Federal Circuit in Amgen v. Sandoz. Even Judge Lourie, author of the majority opinion, borrowed Winston Churchill’s phrase to describe the BPCIA: “a riddle wrapped in a mystery inside an enigma.” The CAFC’s decision in Amgen that the biosimilar developer does not have to disclose its application to the reference biologic sponsor may render the BPCIA a nullity and lead to further litigation regarding how the participates should (must?) engage in the patent dance. We will address the implication of the Amgen decision, as well as the earlier Sandoz v. Amgen litigation relating to Enbrel® (etarnercept), we will examine the patent exchange process—the so called, “patent dance”—and look to some other legal avenues where stakeholders have tried to promote or delay the entry of biosimilars to the market.