Contact the author at biotech@biopharma.com or call 301-424-0255 to request access. With the author filing a Citizen Petition with FDA concerning biologics, including biosimilars, nomenclature, his providing too much detailed information on this topic risks confounding and biasing related FDA consideration and public discussions on these topics.

Abstract: There are no simple ways to define and assign useful nomenclature (names and other identifiers) to specific biopharmaceutical products, including biosimilars, which add further levels of complexity. This includes names that are unique, unambiguous and useable (relatively short, pronounceable, etc), and generic names that convey information regarding entity, activity, therapeutic equivalence/substitution, class or other relationships among products. Nomenclature systems that work well for chemical substances and drugs fail when applied to biopharmaceuticals and biogenerics. This article discusses problems with conventional drug/chemical nomenclature and registry systems as applied to biopharmaceuticals, and the controversies likely to be associated with selection of official names, both unique and generic, for biopharmaceuticals, particularly biogenerics. Nomenclature, since it directly affects marketing, particularly the names to be officially adopted (for filling of prescriptions) for biogenerics, will be a very contentious issue. (If not familiar with the most basic aspects of biopharmaceutical and biogeneric terminology (basically, like nomenclature, total chaos), consider looking over What is a Biopharmaceutical? and What is a Generic Biopharmaceutical?...).