Biobetters: Are They Truly Better?

Abstract

Biologics have seen an explosion in application for a myriad of diseases. Recently the term “biobetter” has entered the lexicon of the pharmaceutical industry. This marketing term refers to a drug that is supposedly a “better” version of a reference biologic. By this definition, these biologics must invariably have some improved pharmacologic and/or pharmacokinetic parameters, such as a better safety/efficacy profile. In actuality, this is not necessarily the case. Additionally, to-date there is neither a legal nor regulatory pathway in place for the development of said, biobetters. This lack of any classification has led to its inconsistent and often inaccurate use within scientific literature. To rectify this, a framework for the potential correct use of the term biobetter within scientific literature (not regulatory) has been provided. Additionally, an exhaustive reclassification of any drug that have been previously termed “biobetter” has been conducted. We believe this classification system, specifically: true-biobetter, potential-biobetter, or non-biobetter will prevent further misuse of the term in the scientific community without modifying the clinical application of such biological entities in practice and in research.