Jim Shehan is a co-presenter at Hyman, Phelps & McNamara-Dechert LLP Joint Webinar

Follow-On Biologics: The Latest FDA, FTC, and IP Developments


February 6, 2014

As we near the fourth anniversary of the enactment of the Biologics Price Competition and Innovation Act, which established the first abbreviated approval route for follow-on biologics in the United States, multiple federal agencies, the courts, industry participants, and public advocacy groups are accelerating their engagement over the statutory approval mechanism, its regulatory implementation, and new state-level efforts to fill gaps left unaddressed by the Act.

In November 2013, the FDA signaled its possible receipt of the first biosimilar application. That same month, the U.S. District Court for the Northern District of California issued the first judicial decision touching on the patent dispute resolution mechanism of the Act. On February 4, 2014, the FTC conducted a public workshop to explore competition issues involving biologic medicines and follow-on biologics.