Frank Cheng
Founder and principle senior consultant, Alban Pharma, Hong Kong
Title: Comparison of biosimilar registration guidelines between EU and USA
Biography
Biography: Frank Cheng
Abstract
When a Bio-Pharma plans to develop biosimilar for global market, it is important to understand the regulatory requirements from different destination of the markets. While FDA requires tremendous biological, analytical and clinical trials data on the tier basis, EMA requires clear quality, non-clinical and clinical data on the head-to-head comparison basis. However, US is a single market where as EU is multinational market, this has important impact on the selection of RMPs, which sometimes are critical to the success of biosimilar development and submission.