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

Author

Poetzl, J., Arlt, I., Schaffar, G., von Richter, O., Wöhling, H., and Afonso, M.

Subjects
IMMUNOGENETICS, ETANERCEPT, PHARMACOKINETICS, DRUG efficacy, CASE studies
Abstract

The article discusses a study that demonstrate equivalent efficacy, and comparable safety and immunogenicity of GP2015 and etanercept originator in patients with moderate to severe chronic plaque-type psoriasis. It is mentioned that GP2015 is a proposed etanercept biosimilar. The article adds biosimilarity is established on the basis of the totality of the evidence based on the data from analytical, nonclinical, pharmacokinetic and clinical comparisons with the originator product.

Published
2018
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