Scott Gottlieb, MD: Improving the US Biosimilars Market

Scott Gottlieb, MD, former commissioner of the FDA, discusses how to improve the US biosimilars market.
October 16, 2019


Transcript

I think continuing to try to make it efficient for biosimilars to get claims of interchangeability will help make the products ultimately more competitive. That process, doing the switching studies to get an interchangeability claim, is fairly efficient, but I think there’s things that you can continue to look at in terms of using real-world evidence and looking at how you structure those switching studies to potentially make it more efficient.

Sometimes those studies are hard to enroll because doctors don't want to enroll patients and patients don't want to enroll in those kinds of studies. So, we do need to continue to look at that, but again, I don’t think that is the biggest impediment if you will, or is going to provide the biggest benefit in terms of trying to foster more competition. I think that the greatest changes that we can make are really going to be on the commercial side.
 

x-button

Click here to view Biosimilars CME Activities

Click here to view Biosimilars PTCE Activities

Health economics experts. Managed care professionals. Key clinical specialists. This is where the worlds of clinical, regulatory, and economical outcomes for specialized pharmaceutical biotechnology meet: The Center for Biosimilars is your online resource for emerging technologies, with a focus on improving critical thinking in the field to impact patient outcomes. We’ll discuss the current landscape for advanced health care management—reviewing emerging treatment paradigms, approaches, and considerations—all by authoritative industry voices.

Intellisphere, LLC
2 Clarke Drive
Suite 100
Cranbury, NJ 08512
P: 609-716-7777
F: 609-716-4747
Copyright © 2006-2019 Intellisphere, LLC. All Rights Reserved.