State-of-the-art immunogenicity evaluation in phase 3 confirmatory study (EGALITY) with etanercept biosimilar GP2015

Abstract

Immunogenicity is an important aspect of all biologics. Switching between biological products has triggered intensive discussion on the interchangeability of a biosimilar with its reference medicine, with the main focus being immunogenicity and different perspectives within Europe¹ and the United States.² Given that immunogenicity assay validation and performance characteristics differ from assay to assay, the immunogenicity assay parameters discussed here enable the interpretation of the immunogenicity results.

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