Regulatory Considerations in Approval on Follow‐on Protein Drug Products

Given the rising cost of health care and prescription medications in the U.S. and the expanding role of biologically derived products within the pharmaceutical landscape, multifaceted issues present a challenge to industry, regulators, and legislators alike. Recent FDA approvals provide insight into the technical requirements for approval of well-characterized FOP products. This article provides an overview of the complex scientific, legal, and policy issues facing the development of biogenerics today. Keywords: biogenerics; rules and regulation; food and drug administration (FDA); drug approval