Technical hindrances in establishing biosimilarity- the final lap in the race

Copyright © 2015 ISSR Journals. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. ABSTRACT: Therapeutics by means of complex biological molecules is currently dominating the total drug space. Several such complex biologics nearing patent expiry, various attempts to launch their generic equivalents is on-going. With stringent regulatory guidelines in place, there is a necessity to understand the basic challenges and differences in the area of establishing comparability. A perspective on existing methods is provided which highlights key gaps in the existing technologies. The coming years would see more developments in the tools and platforms that enable comparability studies and statistical methods that can help extrapolate a quantitative measure for biosimilarity