Biosimilar regulation in GCC | 8190
Journal of Developing Drugs

Journal of Developing Drugs
Open Access

ISSN: 2329-6631

+44 7868 792050

Biosimilar regulation in GCC

International Conference and Expo on Generic Drug Market & Contract Manufacturing

November 07-09, 2016 Barcelona, Spain

Abdulmohsen H Alrohaimi

Shaqra University, KSA

Posters & Accepted Abstracts: J Develop Drugs

Abstract :

Biosimilars are the new forms of innovator biopharmaceutical products that are marketed after patent��?s expiration. These are generic versions of medicines obtained from various biological sources that depend on the same mechanism of action, and are used for the same therapeutic indication, as the innovator product. Regulatory agencies evaluate biosimilars based on their level of similarity to, rather than the exact replication of the innovator drug. On the other hand, generics pharmaceuticals are facing various hurdles due to strict regulations at various fronts. Because of tremendous scope in near future, the world is falling behind in the race to make copies of complex biotech drugs, which are expected to meet the huge demand as well generate billions of dollars in sales in the coming years. It has been emerged globally as one of the fastest growing development opportunities in the pharmaceutical sector. Many generic pharmaceuticals companies are switching their mode to biosimilar drugs. There is a tremendous increase in healthcare infrastructure in Gulf Cooperation Council (GCC) country. The increasing rate in neuropsychiatry disorder, cancer and various life-style related diseases in GCC region, it is expected that the total health-care expenditure in GCC country is expected to reach US $60 billion in 2025. However, implication of favorable policies, norms and regulations aimed at reducing industry price, profits and Foreign Direct Investment (FDI). This region also facing challenges like lack of specialized research and development, lack of enough expertise and safety issues. Therefore, GCC seems to be one of the hot destinations for gearing up to take next big jump on biosimilars.