Biobetters: Are They Truly Better?

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