Αρχειοθήκη ιστολογίου

Τρίτη 10 Οκτωβρίου 2017

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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