Regulation, Policy, and Litigation in Biosimilars - Episode 1
Amanda Forys, MSPH: Hello, and thank you for joining The Center for Biosimilars™ Peer Exchange® titled “Regulation, Policy, and Litigation in Biosimilars.” I am Amanda Forys, senior director of Reimbursement Policy Insights at Xcenda. Participating on our distinguished panel are: Ha Kung Wong, partner at Fitzpatrick, Cella, Harper, and Scinto; Molly Burich, associate director of Public Policy: Biosimilars, Pipeline, Reimbursement at Boehringer Ingelheim; and Dr Angus Worthing, practicing rheumatologist at Arthritis and Rheumatism Associates, and chair of the American College of Rheumatology’s Government Affairs Committee. Thank you so much for joining us. Let’s begin.
First, we’re going to talk about biosimilar regulation in the United States and Europe. The FDA is currently reviewing industry feedback on its interchangeability draft guidance. Molly, will biosimilar manufacturers seeking interchangeability have an effect on how reference product sponsors attempt to protect market share?
Molly Burich, MS: That’s a great question. I think it will. I think the purpose of interchangeability, from an FDA standpoint, is really geared towards proving that switching products for any given patient will result in the same clinical outcome as the originator. Therefore, we believe that the designation of interchangeability will be meaningful. It will be meaningful from a patient standpoint. Hopefully, it builds their confidence in the product they’re taking. We really believe it will be meaningful from a physician standpoint, as the data will be built and designed exactly for switching. So, we think it will have an impact on behavior across the industry for those designations when they’re given.
Amanda Forys, MSPH: Thank you.
Ha Kung Wong, JD: Yes, I’d like to also mention something about reference product sponsors (RPS). I think that to a certain extent, they’re really going to move to protect their products even more strongly because of the fact that interchangeables act like traditional small molecule generics. They can kind of piggyback on the marketing and education of the branded drug. And so, they’re going to look for ways to protect and get additional IP (intellectual property). And, I can see a lot more challenges from interchangeable manufacturers on IP that is owned by RPS. In particular, of the interchangeable guidance, they actually talk about how product presentation, for instance, including labeling, packaging, and delivery device design is actually really important and has to be looked at. And because of that, I can see reference product sponsors looking to get IP around those aspects (to kind of protect their market share as well).
Molly Burich, MS: Yes, and that’s a great point. I think that the interchangeability guidance was probably the most long awaited guidance that the FDA released, as it pertains to biosimilars. There were industry, physicians—every stakeholder was really interested to see what the FDA was going to require. I think the reality is, it’s a high bar and appropriately so for what it’s trying to prove.