Regulatory and Legislative Impact on Biosimilars


A review of the regulatory and legislative impact on biosimilars.


Kyle Skiermont, PharmD: Al, 1 of the things we’ve been talking about is the slow uptake of using the biosimilars, and I think that’s been driven somewhat by the slow process or the slow entrance into the marketplace of some of these biosimilars, even when the chemical compound is available but not actually coming to market. So I know, gosh, I think the last I looked, there were 7 or 9 that had been approved, and only a handful of those had reached the market. So 1 of the things we’re seeing now is that with some of the recent changes in legislation, the hope would be that these medications actually get to a point where they are able to be used much more quickly.

Al Heaton, BS, PharmD, RPh: Yeah, I would agree with that, but ironically there’s almost a perverse feel to the new legislation. For example, in our state [Minnesota], the substitution law was amended very significantly to allow for biosimilars, but they put that word in there: interchangeability. And prior to that, it was under the pharmacist’s professional judgment, in terms of substitution. So yes, it updated the law, but, in some respects, handcuffed the ability to substitute.

And again, how the FDA defines interchangeability is a very high bar for a manufacturer producing a biosimilar. And it also puts that little notice factor from pharmacist to physician into the regulation. And most of these drugs that are on the market are on the medically administered side. If we have a biosimilar that comes into the pharmacy side—and it’s a very popular one, for example—then they’ll put that back in the pharmacist’s hands. And I think that process will speed up when that occurs as well.

Kyle Skiermont, PharmD: Yeah, I agree with you. I think some of the challenges are around the interchangeability, and none of the biosimilars today have achieved that status. And as you said, the variability in state law—of being able to make a substitution, what that notification period may be, or what that notification requirement may be to the provider. You know, we’ve seen it, but on the medically administered side—and I think this is what you were getting at—it is actually an easier substitution. Because, 1, you’ve got the provider right there, you’re administering it to the patient. But also, what we’ve seen—at least inside our health system—is the way a lot of the order sets and a lot of the kind of, I’ll call it auto substitution, and that might be a little strong, but…

Al Heaton, BS, PharmD, RPh: Standing orders.

Kyle Skiermont, PharmD: Right, exactly. Allow for that switching much more readily. As you said, if it moves out into a kind of more traditional pharmacy space, it may be that a PBM [pharmacy benefit manager] or other factors may be driving to make that switch but not doing that switch until notifying the prescriber.

Al Heaton, BS, PharmD, RPh: Yeah. And again, we’ve seen a similar thing with a couple of systems, in which their own endogenous and dwelling P&T [pharmacy and therapeutics] committees have said, “Hey, this is nuts. This is what we will use.” And literally overnight there’s a switch that takes place then among those physicians.

Jonathan Ogurchak, PharmD, CSP: So let’s talk for a minute about that slow uptake and why it’s been so slow for the entrance of biosimilars to the market once the compound has actually been made FDA available. A lot of this has to do with patent protection and the difficulty associated with the manufacture of these products. How could you reasonably make this drug without having access to the trade secret, if you will? And every launch has equaled litigation on behalf of the reference manufacturer and, ultimately, a holdup of that commercialization.

It wasn’t until the summer of 2017 that the Supreme Court ruled unanimously that this can no longer hold up a drug’s commercialization on an ongoing basis. Now, state by state, legislation has been updated in 45 states, but it truly just surrounds the language related to interchangeability designations within The Purple Book, and how pharmacists may be able to interchange those drugs at point of sale.

Al Heaton, BS, PharmD, RPh: Have you had the conversation about the reference product, for example, as a biosimilar to itself? I mean, we’ve had some of these products out for 10, 15 years or longer, and they’re not the same as what they were 10 years ago.

Kyle Skiermont, PharmD: Right. Some of our education with providers and patients has been exactly that. Arguably, you could probably even call 1 batch of a reference product to another batch a biosimilar in and of itself, just by the way they’re produced and the nature of the fact that they’re very complex proteins. You know that 1 batch to the next, it’s a tough argument to say they are 100% exactly the same, in particular if manufacturing changes have been made. As you said, we’ve had some of these that have been around for a long time. The manufacturing process for some of these medications has changed from when they were first approved to where they’re at now.

Al Heaton, BS, PharmD, RPh: And it’s changed multiple times.

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