Kamali Chance
Quintiles, Inc, USA
Title: FDA/EMA Current thinking on totality of evidence for biosimilar approvals
Biography
Biography: Kamali Chance
Abstract
The regulatory landscape for the development of biosimilars in the US and EU is dynamic as many of the guidance issued by European Medicines Agency (EMA) have recently undergone revisions and the FDA has issued number of revised guidelines for Quality and Scientific Considerations as well as updated Questions and Answers documents that lend much clarity. FDA has also issued draft guidelines for Nonproprietary Naming of Biological Products as well as Labeling guidelines for biosimilars. This session is designed to provide current status of biosimilar guidelines in the US and EU. The focus will be to identify major updates in order to help sponsors navigate through the complex requirements for the regulatory approval of biosimilars in the US and EU.