Functional and Nonclinical Similarity of ABP 980, a Biosimilar of Trastuzumab.

ABSTRACT: PURPOSE:The in vitro and in vivo pharmacologic assessment of ABP 980 similarity to its reference product is intended to compare the activity of ABP 980 and trastuzumab and support the overall conclusion of similarity based on a comprehensive analytical and functional evaluation. METHODS:This work complements the primary assessment of functional similarity with additional in vitro assays, binding studies, and non-clinical studies including human epidermal growth factor receptor-2 (HER2) kinetic binding, HER2 signaling, HER2 internalization, synergy with docetaxel chemotherapy, FcγR kinetic binding, primary natural killer and monocyte cell binding, antibody-dependent cellular phagocytosis activity, in vivo xenograft studies, and toxicokinetic parameters. RESULTS:The results contribute to the

SUBMITTER: Jassem S 

PROVIDER: S-EPMC6834741 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature