Biologic drugs are expensive, and hence policymakers are considering accelerating copies, or "follow on" biologic products to market using abbreviated pathways. However, important concerns relating to biologic products may have implications for follow on product regulation. The information gaps regarding biologic science, clinical issues associated with product excipients and active ingredient, and supply chain issues and weaknesses call for a regulatory system different from abbreviated approvals for chemical drugs. This article concludes that a policymaker focus upon patient safety rather than any potential reduction in price is appropriate for follow on biological products.

Safety Issues in Regulating Follow-On Biologic Drugs