Scott Lassman: Products to be Regulated as Biologics by 2020

Transcript:

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.