Related Experiment Video
Updated: Dec 20, 2025

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
Analytical and Functional Similarity Assessment of ABP 710, a Biosimilar to Infliximab Reference Product
Ramsey Saleem1, Greg Cantin1, Mats Wikström1
1Amgen Inc., Thousand Oaks, California, USA.
Purpose:
ABP 710 has been developed as a biosimilar to infliximab reference product (RP). The objective of this study was to assess analytical similarity (structural and functional) between ABP 710 and infliximab RP licensed by the United States Food and Drug Administration (infliximab [US]) and the European Union (infliximab [EU]), using sensitive, state-of-the-art analytical methods capable of detecting minor differences in product quality attributes.
Methods:
Comprehensive analytical characterization utilizing orthogonal techniques was performed with 14 to 28 unique lots of ABP 710 or infliximab RP, depending on the assay. Comparisons were used to investigate the primary structure related to amino acid sequence; post-translational modifications (PTMs) including glycans; higher order structure; particles and aggregates; primary biological properties mediated by target and receptor binding; product-related substances and impurities; and general properties.
Results:
ABP 710 had the same amino acid sequence, primary structure, higher order structure, PTM profiles and biological activities as infliximab RP. The finished drug product had the same strength (protein content and concentration) as infliximab RP.
Conclusions:
Based on the comprehensive analytical similarity assessment, ABP 710 was found to be highly analytically similar to infliximab RP for all biological activities relevant for clinical efficacy and safety.
More Related Videos
11:09An HS-MRM Assay for the Quantification of Host-cell Proteins in Protein Biopharmaceuticals by Liquid Chromatography Ion Mobility QTOF Mass Spectrometry
Published on: April 17, 2018
13:49Semi-automated Biopanning of Bacterial Display Libraries for Peptide Affinity Reagent Discovery and Analysis of Resulting Isolates
Published on: December 6, 2017
Related Concept Videos
Drug Products: Biologics, Biosimilars and Interchangeables
Bioequivalence: Overview
Bioequivalence Data: Statistical Interpretation
Pharmaceutical Equivalents
Bioequivalence studies: Biowaivers
Bioequivalence of Drugs: Drugs with Multiple Indications