Alexandra Valenti, JD: The 2020 Transition of Insulins to Regulation as Biologics

Alexandra Valenti, JD, partner at Goodwin, discusses what drug makers should consider as the United States approaches a regulatory transition for insulins.
October 11, 2019


So, the FDA has released guidance indicating that insulin and other products that, for historical reasons, were previously regulated as small molecules will be transitioned to be regulated as biologics. And, this raises a couple issues for drug manufacturers.

One is that if you submit an application for, let’s say insulin, ahead of the transition date in March of 2020 and the application is not yet approved as of March 23, 2020, your application would need to be resubmitted under what will be the new framework for that product under the biologics regulatory framework.

So, that creates this period that we’re in right now, really, where companies probably won’t be filing applications on these products because there’s that risk of not being approved in time and then having to restart the whole process. So, it just makes more sense to wait until March 2020, basically, to go ahead and submit the application.

The other issue is if those new applications do have to get filed, what are the consequences of that? Does it reinitiate patent dance procedures under the [Biologics Price Competition and Innovation Act, BPCIA]? Other kind of regulatory issues having to do with the new application that you would need to submit, and so we do have this situation now where there is sort of a disincentive to go ahead and file applications on these molecules because there is so much uncertainty about what happens on the transition date if I’m under development as it stands now.


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