Demonstration of Physicochemical and Functional Similarity of Biosimilar Adalimumab-aqvh to Adalimumab.

ABSTRACT:

Background

Adalimumab-aqvh/CHS-1420 (YUSIMRY^TM) (hereafter referred to as adalimumab-aqvh) was recently approved by the US Food and Drug Administration as a biosimilar for adalimumab.

Objective

The current study was conducted to investigate the analytical similarity of adalimumab-aqvh and the reference product, adalimumab.

Methods

The structural, functional, and stability attributes of adalimumab-aqvh and adalimumab were compared using state-of-the-art assays. The primary structure, disulfide structure, glycan profile, secondary and tertiary structures, molar mass, size variants, free thiol, charge variants, hydrophobic variants, post-translational modifications, subvisible particles, host cell proteins, and protein concentration were investigated. The func

SUBMITTER: Jiang Y 

PROVIDER: S-EPMC10676336 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature