title: Assessing Analytical Similarity of Proposed Amgen Biosimilar ABP 501 to Adalimumab.
abstract: BACKGROUND
  ABP 501 is being developed as a biosimilar to adalimumab. Comprehensive comparative analytical characterization studies have been conducted and completed.
  
  
  OBJECTIVE
  The objective of this study was to assess analytical similarity between ABP 501 and two adalimumab reference products (RPs), licensed by the United States Food and Drug Administration (adalimumab [US]) and authorized by the European Union (adalimumab [EU]), using state-of-the-art analytical methods.
  
  
  METHODS
  Comprehensive analytical characterization incorporating orthogonal analytical techniques was used to compare products. Physicochemical property comparisons comprised the primary structure related to amino acid sequence and post-translational modifications including glycans; higher-order structure; primary biological properties mediated by target and receptor binding; product-related substances and impurities; host-cell impurities; general properties of the finished drug product, including strength and formulation; subvisible and submicron particles and aggregates; and forced thermal degradation.
  
  
  RESULTS
  ABP 501 had the same amino acid sequence and similar post-translational modification profiles compared with adalimumab RPs. Primary structure, higher-order structure, and biological activities were similar for the three products. Product-related size and charge variants and aggregate and particle levels were also similar. ABP 501 had very low residual host-cell protein and DNA. The finished ABP 501 drug product has the same strength with regard to protein concentration and fill volume as adalimumab RPs. ABP 501 and the RPs had a similar stability profile both in normal storage and thermal stress conditions.
  
  
  CONCLUSIONS
  Based on the comprehensive analytical similarity assessment, ABP 501 was found to be similar to adalimumab with respect to physicochemical and biological properties.
authors.affiliation: Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA. jliu@amgen.com.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Liu
authors.affiliation: Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.
authors.forename: Tamer
authors.initials: T
authors.lastname: Eris
authors.affiliation: Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.
authors.forename: Cynthia
authors.initials: C
authors.lastname: Li
authors.affiliation: Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.
authors.forename: Shawn
authors.initials: S
authors.lastname: Cao
authors.affiliation: Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.
authors.forename: Scott
authors.initials: S
authors.lastname: Kuhns
mesh_terms: D000068879:Adalimumab / Q000737:chemistry* / Q000494:pharmacology; D000818:Animals; D059451:Biosimilar Pharmaceuticals / Q000032:analysis* / Q000737:chemistry* / Q000494:pharmacology*; D016466:CHO Cells / Q000187:drug effects; D002152:Calorimetry, Differential Scanning; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D002942:Circular Dichroism; D003412:Cricetulus; D004355:Drug Stability; D000067493:Dynamic Light Scattering; D019075:Electrophoresis, Capillary / Q000379:methods; D007526:Isoelectric Point; D010449:Peptide Mapping; D017550:Spectroscopy, Fourier Transform Infrared; D014461:Ultracentrifugation
chemical_list: D059451:Biosimilar Pharmaceuticals; D000068879:Adalimumab