Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, explains differences between follow-ons and biosimilars.
Does a designation of an innovator product as a drug as opposed to a biologic make it easier or harder to enter the market with a follow-on?
It really depends on the specific product you’re talking about. In some cases, it could be easier, in some cases it could be harder. I will say upfront that very soon, in 2020, all those products, like insulin, which are now regulated as drugs and get approved through NDAs and 505(b)(2) applications, they’re all going to be transitioned to biologics and they’re going to have to submit BLAs.
So, this issue won’t exist for much longer. But again, given the current state it really does depend on the particular drug involved. So for products like insulin that are currently regulated as drugs, there are two pathways to get approval of a “generic.” There’s the NDA pathway and the 505(b)(2) pathway. I think a lot of these products are probably so complex that the NDA pathway isn’t a very realistic possibility.
The FDA will take the position, and has taken the position, that you can’t really demonstrate that the active ingredients are the same. On the other hand, if it were regulated as a biologic and you could do a biosimilar, biosimilars don’t have to be identical. In that sense, it might be easier for some of these products to get approval as a biosimilar because you don’t have to show the level of identity that you do to get an ANDA. The other thing is that biosimilars can be supported by clinical data whereas NDAs cannot. I guess the third issue that folks need to look at is the level of exclusivity. Biologics have 14 years of exclusivity, so if you’re blocked by that, that’s going to be a lot longer than you’d be blocked if the product were subject to an NDA. The longest exclusivity period is 5 years, and even adding on the delays for potential patent litigations, the most it’s going to be is 30 months. In some cases if you’re looking at a reference product that has the 14 years of exclusivity, you’d probably prefer that it were regulated as a drug rather than a biologic.