Biosimilars in India

Abstract

Biosimilars have been defined as biotech drugs that have been shown to have comparable quality, safety and efficacy to the original product. The past decade has seen a significant increase in interest in these products from the biotech industry. Major developments have occurred with respect to establishing a regulatory path for approval of these products as well as in our understanding of how the different quality attributes of a biosimilar impact its safety and efficacy. India is globally regarded to have great potential to become a significant player in development and commercialization of biosimilars. This short communication aims to provide a brief discussion on where India is with respect to development and commercialization of biosimilars, major challenges it faces, and finally the significant role that proteomics can play in establishing analytical comparability of biosimilars.This article is part of a Special Issue entitled: Proteomics in India.