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Tuesday, June 26 • 10:30am - 11:45am
#240: Biosimilars: Demonstrating Structural and Functional Similarity

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-584-L04-P; CME 1.25; IACET 1.25; RN 1.25

Biosimilar products continue to advance, with many companies investing in this field. The biosimilarity paradigm is based on reducing clinical and non-clinical data to the extent possible, based on robust comparison of the biosimilar product versus the authorized reference medicine. This session will look at the quality foundation for building the biosimilarity exercise and elaborate on experiences gained with authorized products and those in development. The utility of physicochemical and bioassays for characterization will be highlighted with a focus on monoclonal antibodies as example.

Learning Objectives

Discuss analytical and functional assays used to develop a biosimilar monoclonal antibody; Identify how robust quality characterization data may enable reduction of clinical requirements; Describe an awareness of technical challenges and regulatory thinking related to biosimilarity at quality level.


T. G. Venkateshwaran, PhD


Biosimilar Development: The Product Defines the Process
Richard Markus

Critical Quality Attributes and Biosimilars Development
Rajesh Ullanat

Building a Strong Analytical Foundation to Support Biosimilarity
Christopher Downey, PhD

avatar for Christopher Downey

Christopher Downey

Review Chief, OBP, OPQ, CDER, FDA
Christopher (Chris) Downey is a Review Chief in FDA/CDER’s Office of Biotechnology Products (OBP). He was been with FDA since 2012, and currently oversees CMC reviews of therapeutic proteins, including new molecular entities and biosimilars. He received his PhD in Biochemistry from... Read More →
avatar for Richard Markus

Richard Markus

Vice President, Global Development, Amgen Inc.
Richard Markus is Vice President, Global Development at Amgen, where he leads development activities for the Biosimilar Business Unit. He received his BS degree from the University of California, Los Angeles (UCLA) and his MD/PhD at the University of Southern California, where he... Read More →

Rajesh Ullanat

Head, Global Biologics Research and Development, Mylan Pharmaceuticals
Dr Ullanat has significant experience in key senior management positions leading multi-functional teams associated with Biopharmaceutical R&D. Dr Ullanat has significant experience related to Global Biosimilar development especially with respect to EMA and US-FDA and has led regulatory... Read More →
avatar for T. Venkateshwaran

T. Venkateshwaran

Associate Vice President and Global Head CMC Biologics, Medical Devices and Comb, Merck & Co., Inc.
T.G. Venkateshwaran (TG) currently serves as an associate vice president - Chemistry, Manufacturing & Controls Biologics and Combination Products, GRACS,Merck. TG joined Merck in November 2015 and has 18 years of pharmaceutical industry experience in R&D, quality, regulatory and manufacturing... Read More →

Tuesday June 26, 2018 10:30am - 11:45am EDT
Room 253C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  10: RegCMC-Product Quality, Session