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.
Review: Product Attributes Relevant to Injection-Site Pain, Adalimumab Treatment
May 4th 2024A review article summarized the product attributes of reference and biosimilar adalimumab products, such as formulation with or without citrate, delivery volume, and needle gauge, relevant to patients’ experience of injection-site pain.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Biosimilars Rheumatology Roundup for February 2024—Podcast Edition
March 3rd 2024On this episode of Not So Different, The Center for Biosimilars® revisited all the major rheumatology biosimilar news from February 2024, including the FDA approval of the 10th adalimumab biosimilar, the promise for an oral delivery system for ustekinumab, and the impact of adalimumab products on COVID-19 antibodies.
Eye on Pharma: EU Ustekinumab Approval; New Golimumab Data; Evernorth Adds Humira Biosimilar
April 29th 2024The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.