Regulation, Policy, and Litigation in Biosimilars - Episode 6
Amanda Forys, MSPH: Now we’re going to talk about reform at the agency state and federal levels, which is definitely an interesting topic in today’s political climate. Let’s talk about the FDA first. In the FDA’s drug price action plan, the agency explains that it will prioritize the review of generic drug applications until there are 3 approved generics for a given small-molecule drug. Is there any expectation that the FDA would do this for biosimilar products?
Ha Kung Wong, JD: I don’t know if there will be, but I think it’s a possibility. My only concern is that I don’t think that it actually gets them to the market any faster. In the typical situation, you’re looking at this new biologic exclusivity that exists, and that’s a 12-year period where you can’t get approval of a biosimilar anyway. In getting priority review, the FDA can be slow, but 12 years slow is pretty slow. I don’t know if that’s going to be an issue. Now, that does make a difference, obviously, to some of the things that are being looked at today. Like Zarxio and Sandoz v Amgen, that regulatory exclusivity is already gone. In that respect, perhaps that might help, but I don’t really see the real benefit. With the small molecules, that was kind of a policy that was put in place in light of this high profile Daraprim and EpiPen (epinephrine) stuff that was going on in 2016. Their goal was to try to increase competitors for products that have already gone generic. That’s not really an analogous situation to a biologic BLA [biologics license application] product and biosimilars.
Amanda Forys, MSPH: That’s an interesting perspective. Molly, do manufacturers see this issue differently?
Molly Burich, MS: I agree with much of what Ha Kung said. I also think part of it is that we’re 30-plus years into the generic pathway. At this point, the FDA, in particular, Commissioner Scott Gottlieb—who has probably been one of the more vocal FDA commissioners on lowering drug prices, given what a challenge they are in the United States for patients to handle—is broadly trying to implement policies on a pathway that’s been around for a while. We’ve certainly seen success in lowering drug cost and high levels of generic utilization across the country. I think that it’s probably too soon to implement something like that for the biosimilar pathway.
I agree with Ha Kung that I’m not sure it really speeds anything up. I think that the commissioner’s comments in support of the biosimilar pathway are important to hear, and it’s great to see that the head official at the FDA is supportive of this pathway that obviously was implemented in a different administration. I think that the commissioner and his deputies will continue to support the pathway, and I can certainly envision, down the road, that we’ll learn things that we don’t know right now. We are 7 years in with 7 approved products, and only 3 launched. So, I think we’re in our infancy and we won’t see any type of policy like this, but I do think Commissioner Scott Gottlieb is focused on lowering drug prices. We certainly, as a manufacturer, believe biosimilars is one part of the solution for that.
Amanda Forys, MSPH: Do you expect the FDA’s recent announcement of a new alignment between the Center for Drug Evaluation and Research and the Office of Regulatory Affairs to speed up the process of drug approvals?
Molly Burich, MS: I think internal alignment in the FDA is probably always beneficial. I think that the FDA has a very wide purview on what they manage. Of course, drugs are a big part of it, and that’s certainly the part that people pay a lot of attention to. So, I think internal alignment and removing some of the backlog that we’ve seen in generic approvals is important. Again, I don’t know how much of that applies to biosimilars, given the infancy and also given the complexity of biologics, quite frankly. But, I do think improved alignment is probably always best for patients to be able to get more competitively priced products that are safe and effective, and the FDA is doing their job in that way.
Angus Worthing, MD, FACR, FACP: Our goal here seems to be to improve the public health response to keep pace with acceleration and scientific innovation in a way that establishes modern legal authorities and also allows for global expansion of markets. At the American College of Rheumatology, we’re excited about anything that will speed safe and effective drugs into the marketplace, because it lowers cost and increases access. So, we’re excited to see Commissioner Scott Gottlieb leading some innovative concepts. This kind of intracenter, or intraagency cooperation is probably going to be helpful, especially because we’ve noticed that there are a lot of positions that the FDA has unfilled. It is sometimes difficult to hire the experts that are needed to issue the guidance and approve the drugs. So, this kind of innovation can only be helpful in getting drugs out of the pipeline and into the marketplace.
Ha Kung Wong, JD: I’ll also just comment, though—I don’t know how much faster things will get. I often say that things are slow, but the FDA has actually been pretty good about getting NDAs [new drug applications] approved. According to the FDA, in 2016, there were 159 more ANDA approvals than in 2015; and 242 more NDA approvals than in 2014. The fact of the matter is, NDA approvals are actually getting through the FDA relatively quickly, so I’m not sure if it’s really necessary to make it any faster. Obviously, the safety and efficacy portion is what we really care about.