Biologics, or drugs developed from biological sources, have taken the pharma world by storm over past decade. Many top best-selling drugs in 2014, were biologics indicated for either autoimmune disorders or cancer..There are variety of features of biologics including their ability to effectively control a range of diseases, their premium pricing structures, and a tendency toward a long shelf life stemming from the onerous U.S. regulatory pathway for the development and approval of generic versions known as "biosimilars". Food and Drug Administration approved its first biosimilar with Novartis named ZarxioTM earlier this year as a less costly replacement for Amgen's white blood cell-boosting Neupogen,but still there are hurdles on the regulatory front in US market.the main issue is that these biosimars can't be exact replicas of approved biological drugs . Besides regulatory hurdles bio similars are not cost effective too... But still biosimilars can emerge as a growth story in pharma sector in near future.
