Biosimilars 2015

Interact with FDA and international agencies to discuss the latest updates and outlooks for biosimilar regulation, while examining the potential implications for patients and HCPs.

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Session 2: Quality Considerations - Part One

Session Chair(s)

Sundar Ramanan, PhD

Director, Global Biosimilars R&D Policy

Amgen Inc., United States

CMC forms the foundation for Biosimilar development. Topics will focus on the nature biosimilar profile in comparison with the reference product and what highly similar means; the nature of tools and techniques used to describe “finger printing”; equivalence acceptance criteria; role of analytical similarity in extrapolation and how does on go about addressing attributes that are outside the equivalence window.

Speaker(s)

FDA Address

Steven Kozlowski, MD

FDA, United States

Director, Office of Biotechnology Products, OPQ, CDER

Challenges and Approaches in Demonstrating Biosimilarity and How to Move Toward Fingerprint-Like Equivalence

Joseph L Glajch

Momenta Pharmaceuticals, United States

Director, Analytical Development

Defining the Requisite Components of Interchangeability

Paul Tebbey, PhD, MBA

AbbVie, Inc., United States

Therapeutic Area Lead, Biotherapeutics Global Medical Affairs

PROFILE-NMR: Assessing Higher Order Structure of Formulated Protein Therapeutics

Brad Jordan, PhD

Eli Lilly and Company, United States

Associate Vice President, Regulatory Policy and Strategy