Timothy J Shea
Sterne, Kessler, Goldstein & Fox P.L.L.C., USA
Title: US biosimilars taking flight: Discussion of the key events and cases shaping the US biosimilar landscape
Biography
Biography: Timothy J Shea
Abstract
The Biosimilar Era has arrived in the US! The past few months have seen the first ever FDA approval of a biologic deemed biosimilar to a previously approved biologic, the first cases of the Federal Circuit addressing the scope and interpretation of the US biosimilars statute, and the first patent battles between biosimilar challengers and brand companies. Against this backdrop the broad contours of the US biosimilar landscape is taking shape, and the early strategies of both brand companies and biosimilar developers are being put to the test. This session will highlight the key legal developments in the US biosimilar industry over the past year with particular focus on the patent issues. The session will also outline the strategies being implemented by biosimilar developers to gain an advantages in the critical patent disputes that are central to any biosimilar launch, as well as the strategies of brand companies in attempting hold off biosimilar competition for as long as possible. We will also discuss which of these strategies are working, and whether they are applicable only to this "first wave" of biosimilar development, or whether they will have long term applicability.