title: Physicochemical characterization of Remsima.
abstract: Remsima (infliximab) was recently approved as the world's first biosimilar monoclonal antibody (mAb) in both the European Union and Korea. To achieve this, extensive physicochemical characterization of Remsima in relation to Remicade was conducted in order to demonstrate the highly similar properties between the two molecules. A multitude of state-of-the-art analyses revealed that Remsima has identical primary as well as indistinguishable higher order structures compared with the original product. Monomer and aggregate contents of Remsima were also found to be comparable with those of Remicade. In terms of charge isoforms, although Remsima was observed to contain slightly less basic variants than the original antibody, the difference was shown to be largely due to the presence of C-terminal lysine. On the other hand, this lysine was found to be rapidly clipped inside serum in vitro and in vivo, suggesting it has no effect on the biological potency or safety of the drug. Analysis of the glycan contents of the antibodies showed comparable glycan types and distributions. Recent results of clinical studies have further confirmed that the two antibody products are highly similar to each other. Based on this research as well as previous clinical and non-clinical comparability studies, Remsima can be considered as a highly similar molecule to Remicade in terms of physicochemical properties, efficacy, and safety for its final approval as a biosimilar product to Remicade.
authors.affiliation: a R&D Division; Celltrion Inc. ; Incheon , Korea.
authors.forename: Soon Kwan
authors.initials: SK
authors.lastname: Jung
authors.forename: Kyoung Hoon
authors.initials: KH
authors.lastname: Lee
authors.forename: Jae Won
authors.initials: JW
authors.lastname: Jeon
authors.forename: Joon Won
authors.initials: JW
authors.lastname: Lee
authors.forename: Byoung Oh
authors.initials: BO
authors.lastname: Kwon
authors.forename: Yeon Jung
authors.initials: YJ
authors.lastname: Kim
authors.forename: Jin Soo
authors.initials: JS
authors.lastname: Bae
authors.forename: Dong-Il
authors.initials: DI
authors.lastname: Kim
authors.forename: Soo Young
authors.initials: SY
authors.lastname: Lee
authors.forename: Shin Jae
authors.initials: SJ
authors.lastname: Chang
mesh_terms: D000911:Antibodies, Monoclonal / Q000737:chemistry* / Q000494:pharmacology; D017209:Apoptosis / Q000187:drug effects; D059451:Biosimilar Pharmaceuticals / Q000737:chemistry* / Q000494:pharmacology; D002152:Calorimetry, Differential Scanning; D055598:Chemical Phenomena; D002851:Chromatography, High Pressure Liquid; D002942:Circular Dichroism; D018360:Crystallography, X-Ray; D017277:Drug Approval; D006031:Glycosylation; D006801:Humans; D000069285:Infliximab; D019169:Jurkat Cells; D013058:Mass Spectrometry / Q000379:methods; D008958:Models, Molecular; D010449:Peptide Mapping; D011487:Protein Conformation; D017550:Spectroscopy, Fourier Transform Infrared
chemical_list: D000911:Antibodies, Monoclonal; D059451:Biosimilar Pharmaceuticals; C000591237:CT-P13; D000069285:Infliximab
keywords: CT-P13; Remicade®; Remsima®; biosimilar; characterization; comparability; infliximab; reference medicinal product (RMP)