Analytical similarity assessment of rituximab biosimilar CT-P10 to reference medicinal product

MAbs
Kyoung Hoon LeeShin Jae Chang

Abstract

CT-P10 (Truxima™) was recently approved as the world's first rituximab biosimilar product in the European Union (EU) and South Korea. To demonstrate biosimilarity of CT-P10 with the reference medicinal product (RMP), extensive 3-way similarity assessment has been conducted between CT-P10, EU-Rituximab and US-Rituximab, focusing on the physicochemical and biological quality attributes. A multitude of state-of-the-art analyses revealed that CT-P10 has identical primary and higher order structures compared to the original product. Purity/impurity profiles of CT-P10 measured by the levels of aggregates, fragments, non-glycosylated form and process-related impurities were also found to be comparable with those of RMPs. In terms of the post-translational modification, CT-P10 contains slightly less N-terminal pyro-glutamate variant, which has been known not to affect product efficacy or safety. Oligosaccharide profiling has revealed that, although CT-P10 contains the same conserved glycan species and relative proportion with the RMPs, the content of total afucosylated glycan in CT-P10 was slightly higher than in EU- or US-Rituximab. Nevertheless, the effect of the observed level of afucosylation in CT-P10 drug product on Fc receptor b...Continue Reading

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Citations

Jul 30, 2019·Expert Review of Proteomics·Amanda HaymondVirginia Espina
Sep 10, 2019·Expert Opinion on Biological Therapy·Ju-Yang JungChang-Hee Suh
Jan 7, 2020·Médecine sciences : M/S·Alain BeckRenaud Respaud
Oct 6, 2020·Expert Opinion on Drug Metabolism & Toxicology·Dae Hyun YooWon Park
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Nov 25, 2021·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Bharati BhardwajaKari L Olson

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Methods Mentioned

BETA
Infrared
Differential
circular dichroism
light scattering
ion-exchange chromatography
glycosylation
flow cytometry
ELISA
electrophoresis
IEC

Software Mentioned

GraphPad Prism
GraphPad Prism®
SEDFIT
Quantity One
BIAevaluation
Origin

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