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Biosimilars: Demonstrating Structural and Functional Similarity
Session Chair(s)
T. Venkateshwaran, PhD
Vice President and Global Head CMC Biologics, Medical Devices and Comb
Merck & Co., Inc., United States
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 Objective : 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.
Speaker(s)
Biosimilar Development: The Product Defines the Process
Richard Markus, MD, PhD
Amgen Inc., United States
Vice President, Global Development
Critical Quality Attributes and Biosimilars Development
Rajesh Ullanat
Mylan Pharmaceuticals, India
Head, Global Biologics Research and Development
Building a Strong Analytical Foundation to Support Biosimilarity
Christopher Downey, PhD
FDA, United States
Review Chief, OBP, OPQ, CDER
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