Biosimilars: Demonstrating Structural and Functional Similarity
Emily Shacter, PhD
ThinkFDA, LLC, 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 characterisation data may enable reduction of clinical requirements; Describe an awareness of technical challenges and regulatory thinking related to biosimilarity at quality level.