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Updated: Apr 19, 2026

An HS-MRM Assay for the Quantification of Host-cell Proteins in Protein Biopharmaceuticals by Liquid Chromatography Ion Mobility QTOF Mass Spectrometry
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Physicochemical characterization of Remsima.

Soon Kwan Jung1, Kyoung Hoon Lee, Jae Won Jeon

  • 1a R&D Division; Celltrion Inc. ; Incheon , Korea.

Mabs
|December 18, 2014
PubMed
Summary

Remsima, the first biosimilar monoclonal antibody (mAb), demonstrates high similarity to Remicade in structure, function, and safety. Extensive characterization confirms Remsima

Keywords:
CT-P13Remicade®Remsima®biosimilarcharacterizationcomparabilityinfliximabreference medicinal product (RMP)

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Area of Science:

  • Biopharmaceutical characterization
  • Monoclonal antibody (mAb) biosimilars

Background:

  • Remsima is the first approved biosimilar monoclonal antibody (mAb).
  • Approval required extensive physicochemical characterization against Remicade.

Purpose of the Study:

  • To demonstrate the high similarity between Remsima and Remicade.
  • To support Remsima's approval as a biosimilar product.

Main Methods:

  • State-of-the-art physicochemical analyses.
  • Comparison of primary and higher order structures.
  • Analysis of monomer/aggregate content, charge isoforms, and glycan profiles.
  • In vitro and in vivo serum stability assessments.
  • Review of clinical and non-clinical comparability studies.

Main Results:

  • Remsima exhibits identical primary and indistinguishable higher order structures to Remicade.
  • Comparable monomer and aggregate contents were observed.
  • Minor differences in charge isoforms (C-terminal lysine) were found to be clinically insignificant.
  • Comparable glycan types and distributions were confirmed.
  • Clinical studies further validated the high similarity.

Conclusions:

  • Remsima is highly similar to Remicade in physicochemical properties, efficacy, and safety.
  • The characterization data supports Remsima's designation as a biosimilar.