Totality of Evidence Supporting the Use of ABP 980, a Trastuzumab Biosimilar: Practical Considerations.

ABSTRACT: ABP 980 (KANJINTI™, Amgen, Thousand Oaks, CA, USA; Amgen Europe B.V., The Netherlands) is a biosimilar to trastuzumab (Herceptin^®), a monoclonal antibody that selectively binds human epidermal growth factor receptor-2 (HER2). Here we provide a brief overview of the totality of evidence (including analytical [structural and functional] characterization, nonclinical evaluation, and human pharmacokinetic [PK], pharmacodynamic, and clinical assessment comparing ABP 980 with trastuzumab reference product [RP]) that supported the approval of ABP 980, along with practical considerations on the reconstitution and use of the lyophilized product to ensure safe and effective administration. ABP 980 has been shown to be highly similar to the RP, with similar mechanism of action, binding, an

SUBMITTER: Kolberg HC 

PROVIDER: S-EPMC8297514 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature