Biobetters: the Better Biologics and Their Regulatory Overview

The term biobetter also known as biosuperior which refers to a recombinant protein drug that is in the same class as an existing biopharmaceutical but is not identical; it is improved over the original. Biobetters are better in one or more product characteristics. Product individuality often targeted by biobetter applicants includes longer product half-life in the body, lower likelihood of aggregation, greater efficacy and purity or fewer adverse events. Biobetters are constructed on the achievements of existing, approved biologics but are considered to have less commercial risk than developing a brand new category of biologic. (2, 3)