From Drugs To Biologics: Considerations For The FDA's Insulin Transition

In line with a Congressional directive, the FDA must transition products previously approved as drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to biologics under the Public Health Service Act (PHS Act) by March 23, 2020. Though this directive applies to 90 soon-to-be biologic products, including growth hormones, the insulin products have been garnering the most attention. Following this transition, biosimilar makers investing in follow-on biologics to current branded products will have their products approved via the 351(k) biosimilars pathway. Novel products will be transferred to the 351(a) biologics pathway. This collection of articles examines the upcoming regulatory transition in depth, sharing industry and patient perspectives on the changing regulatory requirements and market access strategies and concerns for this critical class of medicines.