This presentation will focus on the FDA’s expectations regarding analytical similarity data that should be submitted to the FDA during clinical development and with a 351(k) BLA submission.  These expectations also apply to analytical bridging studies between the US-licensed reference product and the non-US approved comparator product in order to leverage non-clinical and clinical data where the proposed biosimilar product was compared to a non-US approved comparator product.  An “A-Mab” case study will be presented as an example of how the Agency thinks about different product quality attributes and examples from approved biosimilar products will be provided.

FDA perspective on demonstrating analytical similarity

253rd National Meeting (2017)

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