Growth potential of biosimilars in emerging countries

<p>Md Abu Zafor Sadek</p>

Growth potential of biosimilars in emerging countries

Md Abu Zafor Sadek

University of Dhaka, Bangladesh

: J Pharm Sci Emerg Drugs

Abstract

In view of the global changes in disease pattern, reduced health budget, patent expiry of some high valued products and side effects of chemical drugs, global pharmaceutical giants are concentrating on biotech products among which anticancer and cardiovascular, antidiabetic, antiasthmatic, antiarthritic products are specially important. However, developing a biotech product involved huge cost which is possible only by research based top companies. Realizing the fact, many pharmaceutical companies tried to imitate the original biotech products after patent expiry and became successful which bring a breakthrough in terms of health cost. These imitated products are termed as biosimilar products. Although the history of biosimilars started at European Union (EU) in 2006 with single product but currently it has been recognized everywhere in the world and EU have highest 19 biosimilar products. United States Food & Drug Administration (USFDA) was little conservative with biosimilars; nevertheless, they approved the first biosimilar 09 years after EU approval and presently they have three biosimilars which are playing significant role in price cutting of branded biologics. They also have so many biosimilars under pipeline. Emerging economies especially China & India are very aggressive with biosimilars. Considering easy regulation, cheap labor & related cost factors they are in little advantageous than others. Under Pharmaceutical Benefits Scheme Australian government is promoting biosimilars and they already approved 09 biosimilars. Japan, Korea, Canada, South Africa are also encouraging 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. Considering present stumpy growth in pharmaceuticals, geographical location, economic growth, drug policies, expertise etc emerging economies may be an impressive hub for rapid growth of biosimilar products. Therefore, this study will concentrate to determine the growth potential of biosimilars in emerging countries.