Duu-Gong Wu
Director of Regulatory Consulting PPD, USA
Title: Regulatory Update and Overview of Specific Scientific Issues for Development and Approval of Biosimilars in US
Biography
Biography: Duu-Gong Wu
Abstract
The passage of 2009 Biologics Price Competition and Innovation Act of 2009 (BPCI Act) in US established a regulatory pathway for the approval and marketing of biosimilars in US. FDA subsequently published a number of general guidance documents between 2012 and 2015 to provide guidelines to the industry on the regulatory process and clarifies the data requirements for the developments and approval of biosimilars. For the final approval of first biosimilar, Filgrastim, FDA also utilized the publication of advisory committee report to lay out the examples of regulatory and data requirements under current biosimilar law. Futhermore, the recent submission of a biosimilar application for Humira® to both EMA and US FDA also represented a milestone with far reaching implications to the field of biosimilar developments in US. Based on Dr. Wu’s unique regulatory experience at FDA and recent interactions with various regularory agencies on the development of several biosimilar Mabs and therapeutical proteins, the presentation will cover the followings: 1) An update on the current regulatory development in the US, 2) Concept of step-wide approaches in demonstratiion of comparability as recommended by FDA. 3) The unique challenges of complex regulatory and scientific issues in US such as User Fees. consultation meetings, reference products, naming, interchangeability of biosimilars. 4) Recommendations to overcome the challenges for the biosimilar product develoment in US.