FDA, IP, and FTC Developments in the Run-up to the First U.S. Biosimilar Approval


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.

Given the accelerating pace of developments in the run-up to the first U.S. biosimilar approval, Dechert LLP and Hyman, Phelps and McNamara, P.C. conducted a webinar on February 6, 2014 to discuss takeaways from the FTC workshop and to provide updates and insights on the latest FDA, IP, and FTC developments in follow-on biologics. The hour-long webinar is available via the links below: 

Listen to the recording
Download the presentation (PDF)

The presentations from the FTC workshop are available at here.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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