Abstract

Aayush Verma*

ABSTRACT

The development and regulatory approval of biosimilars that are highly comparable with an approved reference drug product has speeded globally in the last few years because of their potential for enhanced patient access and lower healthcare expenses. But the verification of biosimilarity of such complicated biologics as fusion protein, monoclonal antibodies and other highly glycosylated/heterogenous molecules, is still technically and regulatorily challenging. Ther key implications are structural heterogenicity, post translational modification, batch to batch variation, high order structure variation, orthogonal techniques employed to ensure biosimilarity and comparison of primary regulatory paradigms of different regulatory bodies. This overview discusses the key technical, scientific, analytical, regulatory and clinical barriers encountered in the development and approval of development of complex biologics.