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Wayne Winegarden, PhD, Explains the Impact of the BPCIA Regulatory Change


Wayne Winegarden, PhD, talked about the issues and benefits of the FDA's switch to a biologics regulatory pathway for certain products, especially insulin, during the World Biosimilar Congress USA 2020 at the Festival of Biologics USA in San Diego, California.

Wayne Winegarden, PhD, is a senior fellow in business and economics as well as the director for the Center for Medical Economics and Innovation at the Pacific Research Institute in San Francisco, California.


Please explain the significance of the regulatory change to the BPCIA.

It's been 10 years since the [Biologics Price Competition and Innovation Act] BPCIA has passed, and what that meant was the biologics that had come out previously--insulin would be the most important one--were regulated under the FDA small chemical market, and now they're going to be migrating and transferring over to the [biologics license application] BLA. From my perspective, I think there's logic to making the transfer. How that was done was very disconcerting, because it created this dead zone, is how it's been referred to. It was [maybe] 10 or 12 months--people can debate that, but it was a substantial period where you disincentivized competition, because if you had--let's say, for insulin--if you had submitted some type of [application for] a new biosimilar, whatever it would have been, for insulin, and you didn't get it finished prior to the transfer on March 23, well, it's lost, and you'd have to go through that whole process all over again. And it's really too costly. So, what it basically encouraged people to do is shut down any type of innovation to any type of competitor [products] for a very substantial period of time. My guess is it's been at least a year, if not longer. Whatever it's been, hopefully that's coming to an end soon as we transfer over, but we've certainly, I think, paid a price in terms of [no increase in] competition...all that progress has been shut down. That's a real loss to patients, and hopefully, that's coming to an end.

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