Brian Lehman, MBA, MHA, RPh, director, Medical Account Management and Strategic Alliances, Sandoz, discusses the March 2020 transition of insulin to the biologics pathway.
The Biologic Price Competition and Innovation Act actually has a portion of the act in March 23, 2020. The insulin products and similar protein products will become biologic products. So they move from the Food, Drug and Cosmetic Act over to the Public Health Service Act, and they'll go from [New Drug Application] NDAs to [Biologic License Application] BLAs. With that situation, what it's going to allow is biosimilar products to then compete against the 351(a) insulin products, and this competition that's going to occur will help improve affordability and access of insulin products for patients.