MAGIC: Would Circumventing the Biosimilar Approval Process Expedite the Availability of Generic Insulin?
Part of the ACA’s sweeping healthcare reform was the Biologics Price Competition and Innovation (BCPI) Act of 2009, which re-classified certain drugs that had previously been regulated under the Food, Drug and Cosmetic Act. Insulin, for example, has historically been treated as a drug product, but will be classified as a biological product (and, therefore,…