Indication Extrapolation

BPC calls for case-by-case extrapolation determinations based on extensive analytic and clinical data. The FDA should proceed with caution when considering biosimilar application requests for indication extrapolation. Even though one biologic medicine has been proven effective in multiple disease states, it does not necessarily follow that a biosimilar product will have the same effect or efficacy. As such, BPC urges caution in approving indications for diseases for which no clinical data is produced. Additional perspective on this issue provided in our related material.