Demonstrating Analytical Similarity of Trastuzumab Biosimilar HLX02 to Herceptin^® with a Panel of Sensitive and Orthogonal Methods Including a Novel FcγRIIIa Affinity Chromatography Technology.

ABSTRACT:

Background

A biosimilar needs to demonstrate its similarity to the originator reference product (RP) in terms of structural and functional properties as well as nonclinical and clinical outcomes.

Objectives

The aim was to assess the analytical similarity between the trastuzumab biosimilar HLX02 and Europe-sourced Herceptin^® (EU-Herceptin^®) and China-sourced Herceptin^® (CN-Herceptin^®) following a quality-by-design (QbD) quality study and tier-based quality attribute evaluation.

Methods

A panel of highly sensitive and orthogonal methods, including a novel Fc gamma receptor IIIa (FcγRIIIa) affinity chromatography technique that enables quantitative comparison of glycan effects on effector function, was developed for the assessm

SUBMITTER: Xie L 

PROVIDER: S-EPMC7211197 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature