Global Status of Biosimilars and Its Influential Factors

Abstract

The history of biosimilars started at European Union (EU) in 2006 with one product; however, currently it has been recognized everywhere in the world and EU have highest 64 biosimilar products. United States Food & Drug Administration (USFDA) was little unadventurous with biosimilars; nevertheless, they approved the first biosimilar 09 years after EU approval and presently they have 28 biosimilars which are playing significant role in price cutting of branded biologics. They also have so many biosimilars in product pipeline. Economically emerging countries especially China & India are very aggressive with biosimilars. In view of easy regulation, cheap labor & other cost related factors they are in little advantageous than the rivalries. Under Pharmaceutical Benefits Scheme Australian government is encouraging biosimilars and they already approved 20 biosimilars. Japan, Korea, Canada, South Africa are also promoting biosimilars. However, it is worth mentioning that in spite of enormous potentiality and rapid growth till to date biosimilar market is insignificant compared to total pharmaceutical market and success of biosimilars will depend on the acceptance by the physicians, treatment cost reduction, trust on manufacturer, proper information, drug substitution, efficacy, safety etc.