Clay Alspach Explains How Changes in the FDA Will Affect Biosimilars

Clay Alspach, JD, principal, Leavitt Partners, explains how biosimilars will be affected by changes in the FDA under Scott Gottlieb's leadership.

Transcript (slighly modified)

What changes in the FDA under Scott Gottlieb’s leadership do you think will have the best chance of meaningfully impacting drug prices?

It’s clear that drug pricing is a priority for President Trump, and Commissioner Gottlieb at FDA has already taken steps to prioritize generic applications. He’s also put out information on biosimilars to help educate physicians, as well as provide additional guidance for those producing them. So, I think that will be the area where they try to make the most difference.