Abstract
This article examines the United States Pharmacopeia (USP) and its role in assessing the equivalence and inequivalence of biological and biotechnological drug substances and products—a role USP has played since its founding in 1820. A public monograph in theUnited States Pharmacopeia-National Formulary helps practitioners and other interested parties understand how an article’s strenght, quality, and purity should be controlled. Such a monograph is a standard to which all manufactured ingredients and products should conform, and it is a starting point for subsequent-entry manufactures, recognizing that substantial additional one-time characterization studies may be needed to document equivalence. Review of these studies is the province of the regulatory agency, but compendial tests can provide clarity and guidance in the process.
Keywords: US Pharmacopeia, biological or biotechnological drug, equivalence, generic biologics, complex active ingredient
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