Challenges With the Development of Biosimilars in Asia for Western Markets: An Overview and Suggested Solutions.

There is a great interest from companies located in Asia to bring biosimilars into Western markets such as the United States, European Union, and Canada, because these are lucrative markets with patents expiring or close to expiry for many originator biologics. Although many sponsors are successfully developing and marketing biosimilars for their own countries, there is an increasing interest among companies in China, Hong Kong, India, Korea, Taiwan, and other Asian countries in targeting markets in the West. As a result, there is widespread interest among these companies in learning about the requirements for regulatory approval in Western countries. This paper, specifically prepared for this journal's wide readership, presents an overview of common challenges identified while working on global biosimilar programs for companies in Asia targeting registration in the West, and also proffers some suggested solutions.