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.
Phase 3 Study Reports Similar Efficacy Between SB17, Stelara in Psoriasis
October 19th 2024A phase 3, 28-week comparative clinical trial in patients with moderate to severe plaque psoriasis confirmed similarity of the proposed ustekinumab biosimilar SB17 (Samsung Bioepis) to the reference product (Stelara) in efficacy, safety, pharmacokinetics, and immunogenicity.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Biosimilars Oncology Roundup for June 2024—Podcast Edition
July 7th 2024On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
Samsung Bioepis Report Showcases Adalimumab Biosimilar Growth in Market Share
October 11th 2024Adalimumab biosimilars have seen a significant increase in market share, from 2% in early 2024 to 22%, as payers and pharmacy benefit managers begin to prioritize these biosimilars over the reference product, Humira.
Sandoz Report: A Unified Approach to Overcoming Drug Shortages
October 10th 2024A report from Sandoz emphasizes the need for collaboration among stakeholders to eliminate drug shortages impacting over 90% of hospital systems in the US, recommending policy changes and actions to address the ongoing issue, which has caused treatment delays and increased costs.