Format

Send to

Choose Destination
Med Sci (Paris). 2019 Dec;35(12):1146-1152. doi: 10.1051/medsci/2019215. Epub 2020 Jan 6.

[Biosimilar monoclonal antibodies: comparative study of analytical and functional quality].

[Article in French; Abstract available in French from the publisher]

Author information

1
IRPF, Centre d'Immunologie Pierre Fabre (CIPF), 5 avenue Napoléon III, 74160 Saint-Julien en Genevois, France.
2
École des Sciences Pharmaceutiques, Université of Genève, Université de Lausanne, CMU - Rue Michel-Servet, 1, 1206 Genève, Suisse.
3
Université François-Rabelais de Tours, UMR 1100, CHRU de Tours, Service de pharmacie, F-37032 Tours, France - Inserm, Centre d'étude des pathologies respiratoires, UMR 1100, F-37032 Tours, France.

Abstract

in English, French

Biosimilars marketing authorization requires a strict demonstration of similarity with the reference antibody, through preclinical and clinical studies. This article reviews the panel of in vitro physicochemical and functional analyses, which are performed prior to clinical studies. For each critical attribute of the antibody, we detail the commonly used analytical techniques, their working principle and the type of information they may give.

PMID:
31903929
DOI:
10.1051/medsci/2019215

Supplemental Content

Full text links

Icon for EDP Sciences
Loading ...
Support Center