Regulatory Issues for Peptide Drugs

Abstract

Peptides have characteristics of both proteins and small molecules, making them specific to bind to a target, similar to endogenous molecules. Peptide drugs fall in between small molecules and protein/antibody drugs. There is guidance developed for small molecules and proteins by regulatory agencies. However, for peptide drugs, guidance is limited, and FDA provides the guidelines for submission of data for chemistry and manufacturing of synthetic peptides. According to the FDA guidelines, “Peptide is a polymer composed of 40 or fewer amino acids.” In 2013, the US pharmacopeia convention (USP) formed a therapeutic peptide expert panel, and the panel recommended some guidelines for the quality of peptide synthesis and for considering peptides as an active pharmaceutical ingredient. With the anticipated demand for peptide therapeutics in metabolic diseases, autoimmune diseases, and cancer, there is an expanding market for peptide therapeutics in the next 10 years. Hence, a clear-cut regulatory requirement is essential for this class of therapeutics. This chapter covers some of the developments in the regulatory requirements for peptide-based therapeutics.