Marty Makary: “There have been waivers of those switching studies that have…”

“And then on interchangeability, can you say anything? We know the FDA has already approved biosimilars as interchangeable without running the switching studies. What is new that's coming out today? Yeah, first of all, There have been waivers of those switching studies that have been granted by the FDA. Now we're going to issue clear final guidance that those are not required. The uncertainty makes it difficult for drug developers, as you know, Zach, with capital markets, they want predictability.” (24:09–24:15)

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