Regulatory considerations in biosimilars: Asia pacific regions

Abstract

Biosimilars are the biological drugs that are granted after the expiry of the patent of an affirmed innovator. Asia Pacific countries are characterized by significant demand as they account for majority of the world population and poor affordability due to low per capita income in most regions. Some of these countries offer potential to emerge as global suppliers of affordable, safe and efficacious biosimilars. This article highlights the prospects of biosimilars in the Asia Pacific market. Regulatory framework in the various countries is also discussed.

Keywords:

• Approved status
• Asia Pacific – biosimilars
• key players
• market size
• regulatory framework

Disclosure statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Additional information

Funding

This work was funded by the Department of Biotechnology, Ministry of Science and Technology [BT/COE/34/SP15097/2015].