Bruce A. Feinberg, DO: If it isn’t complex enough, we now have not just the FDA involved, from a regulatory side, but we’ve got states weighing in independently. I don’t know to what extent that’s been part of pharmacy regulation, but it is going to be an issue—states weighing in on substitution and status. Are states equipped to do that? Is that going to represent another potential hurdle or barrier?
Marcus H. Snow, MD: Well, I know that, nationally, there is involvement of biosimilars and interchangeability at the pharmacy level. Over 40 states have an active legislation with this because they have to enact legislation in order to substitute. If a physician writes for a product, for it to be substituted, there has to be a law allowing that to happen.
Bruce A. Feinberg, DO: And it’s a state law, not a federal one?
Marcus H. Snow, MD: It’s a state law. It has to be interchangeable. In everything we’ve talked about today, we think they are basically the same. But interchangeable means, at least in the rheumatology sense, when you switch back-and-forth, it involves a switching study. The FDA grants interchangeability status, which is higher than approval for just a simple biosimilar. If you are interchangeable at a state level, there are laws regulating if you can switch, how you can switch, and how the notification from the pharmacist to the provider goes about that switch.
Brandon Shank, PharmD, MPH, BCOP: The regulations are really similar to the AB ratings for small molecules, as far as communicating to the patients and then communicating back to the physicians. The physicians do have the ability to override the substitution by writing “Do not substitute” on the order, which is regulation. But this does vary from state to state. The state boards from each state have taken a different spin on addressing this topic.