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Scott Lassman: Follow-on Biologics and the "Regulatory Dead Zone"


Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, explains how the upcoming transition of follow-on biologics to regulation as biosimilars could create a "regulatory dead zone."


Will product sponsors need to take steps to transition their products to biologic status?

That’s another good question, I think it’s going to be FDA edict. FDA actually put out a draft guidance document a couple of years ago where they described how they see the transition process going. It was severely criticized by a number of people, and I think the biggest complaint is that it creates what folks have described as a “regulatory dead zone.” What FDA has said is, for things like insulin, the statute says you can submit an [New Drug Application, NDA,] until I think it’s March 21, 2020. But the FDA said that if you don’t get approved by that date, we will not review it any longer, and you have to pull that application and submit it as a biosimilar.

Companies, when they look at this, say, “Well, the FDA’s typical review is 10 months, so if we’re thinking about submitting an NDA say, 9 months before that date, chances are it’s not going to get approved, and we’ll have to pull it. So why would we even submit it?”

Typically, things go through a couple of review cycles, so it might even be longer than 10 months. Actually, if you look at the most recent insulin and insulin-like products, FDA’s review was anywhere from 2 to 5 years. Then you have to factor in, well, "What if we’re subject to a 30-month-stay?" A rational player would look at that and say, at some point, "It doesn’t make sense for us to submit an NDA because the risk that it’s not going to get approved is too high, so why don’t we just wait and submit the biosimilar application?"

The problem is that you’ve got this 2- or 3- or 4-year period where no one is submitting anything. I think that one is going to be, we’ll have to see, but I think that one is ripe for litigation because FDA’s position from policy point-of-view doesn’t make any sense, and I think legally it’s very suspect as well.

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