Physicochemical and functional comparability between the proposed biosimilar rituximab GP2013 and originator rituximab.

ABSTRACT:

Background

Regulatory approval for a biosimilar product is provided on the basis of its comparability to an originator product. A thorough physicochemical and functional comparability exercise is a key element in demonstrating biosimilarity. Here we report the characterization of a proposed biosimilar rituximab (GP2013) and originator rituximab.

Objective

To compare GP2013 with originator rituximab using an extensive array of routine analytical and extended characterization methods.

Methods

Primary and higher order protein structures were analyzed using a variety of methods that included high-performance liquid chromatography electrospray ionization mass spectrometry (HPLC-ESI-MS), peptide mapping with UV and MS detection, circular dichroism (CD), Fourier transform in

SUBMITTER: Visser J 

PROVIDER: S-EPMC3775154 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature