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Assessing Analytical and Functional Similarity of Proposed Amgen Biosimilar ABP 980 to Trastuzumab

Authors
  • Hutterer, Katariina M.1
  • Polozova, Alla2
  • Kuhns, Scott1
  • McBride, Helen J.1
  • Cao, Xingxiang1
  • Liu, Jennifer1
  • 1 Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA , Thousand Oaks (United States)
  • 2 Amgen Inc., 360 Binney Street, Cambridge, MA, 02142, USA , Cambridge (United States)
Type
Published Article
Journal
BioDrugs
Publisher
Springer International Publishing
Publication Date
Apr 10, 2019
Volume
33
Issue
3
Pages
321–333
Identifiers
DOI: 10.1007/s40259-019-00350-9
Source
Springer Nature
License
Green

Abstract

BackgroundABP 980 has been developed as a biosimilar to Herceptin® (trastuzumab). Comprehensive analytical characterization incorporating orthogonal analytical techniques was used to compare ABP 980 to trastuzumab reference products sourced from the United States (US) and the European Union (EU).MethodsPhysicochemical property comparisons included the following: primary structure related to amino acid sequence and post-translational modifications, including glycans; higher-order structure; product-related substances and impurities, including size and charge variants; subvisible and submicron particles, and protein content. In addition, functional similarity was assessed for Fab-mediated, Fc-mediated, and combined Fab- and Fc-mediated activities.ResultsABP 980 has the same amino acid sequence as and similar post-translational modification profiles to trastuzumab (US) and trastuzumab (EU). Importantly, ABP 980 was found to be highly similar to trastuzumab for all functional activities related to the mechanism(s) of action. Higher-order structure, product-related substances and impurities, particles and aggregates were also highly similar between ABP 980 and trastuzumab. Where minor differences were noted, they were evaluated and found unlikely to impact clinical performance. The totality of evidence, including the pharmacokinetic clinical similarity of ABP 980, further supports that ABP 980 is highly similar to trastuzumab.ConclusionBased on the comprehensive analytical similarity assessment, ABP 980 is analytically highly similar to the reference product, trastuzumab.

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