Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, explains which products currently regulated as drugs will be transitioned to regulation as biologics by 2020.
What are some drugs that will be transitioned to regulation as biologics in the future?
That’s a good question. I don’t have a list, I think the FDA put out a tentative list. Enoxaparin probably will not because that’s a sugar, and the way the statute was revised is they added the word “protein.” So proteins are now regulated clearly as biologics, and as I said there’s a transition provision, so by 2020, all of these proteins are going to be transitioned.
So it’s really the proteins, I think somatropin is an example of one, insulin is an example of another, enoxaparin I don’t think is because I think that’s more of a sugar molecule, so I don’t think it’s going to necessarily be covered.
It’s mainly the proteins, and then there’s actually a question; there’s been a petition that was filed. There are a number of products called peptides, which are just a little bit smaller than proteins. The FDA’s cut-off I think is 40 amino acids, so you’ve got some of these products that are 38, 39 [amino acids], and there was a petition that was submitted arguing that those ought to be transitioned as well because they’re close enough. It would be interesting to see how that pans out. I think people want it to get transitioned so they can take advantage of this 14 years of exclusivity. But it’s an interesting question and I think folks are going to be fighting that one out in the next couple of years as we get closer to 2020.