Biosimilars and the US-legislation: Analytical and Clinical Challenges

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SELECTBIO

Recent legislation in the US provides a path forward for the licensure of biosimilar proteins; this legislation also allows for the interchangeability of the biosimilar with its reference product. This talk will emphasize some of the analytical and clinical challenges in demonstrating the “highly similar” nature of the biosimilar candidate and reference product, particularly for more complex proteins, such as the monoclonal antibodies.