Abstract

A COMPREHENSIVE REVIEW ON BIOSIMILARS

Kalyani Y.* and Shyamala

Abstract

A biosimilar is a biological medical product highly similar to another already approved biological medicine (the „reference medicine‟), it has introduced many new treatments to life-threatening and rare illnesses. The first generation of biopharmaceutical products manufactured using recombinant technologies was launched in the 1980s and they are now on the way to patent expiration. Biologics are produced by cells in culture or whole organisms, which are inherently more variable than chemical synthesis methods. Therefore, unlike generic pharmaceuticals, it is impossible to generate the same or identical copy of an innovator product. In this way, Biosimilars are “similar but not the same” or in other words biosimilars are “the twin but not the clone” to the original biologic innovator product. These are approved according to same standard of pharmaceutical quality, safety and efficacy that apply to all biological medicines. Biosimilar drugs will overtake small molecule pharma drugs in coming decades. As per Evaluate pharma report, use of biosimilar drugs will continue to rise, contributing to 50per cent of the Top pharma sales by 2022. The uptake of biologics is expected to continue as novel biological block blusters keep entering the pharmaceutical market.

Keywords: Biosimilar, Biologics, Reference product, Non-innovatory product.