Kamali Chance
Vice President, Quintiles, IMS, USA
Title: FDA/EMA current thinking on totality of evidence for development of biosimilars
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 needed clarity. FDA has also issued final guidelines for nonproprietary naming of biological products as well as draft interchangeability guidance. 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.