Population pharmacokinetics of PF-05280014 (a trastuzumab biosimilar) and reference trastuzumab (Herceptin®) in patients with HER2-positive metastatic breast cancer.

Affiliation

Early Oncology Development and Clinical Research, Pfizer Inc., 10777 Science Center Drive, San Diego, CA, 92121, USA. [Email]

Abstract

PF-05280014 is a biosimilar to trastuzumab (Herceptin®). Following demonstration of pharmacokinetic (PK) similarity in healthy volunteers, a comparative clinical study in patients with HER2-positive metastatic breast cancer (mBC) compared the efficacy, safety and immunogenicity of PF-05280014 and trastuzumab sourced from the EU (trastuzumab-EU), both with paclitaxel.

Keywords

Biosimilar,Human epidermal growth factor receptor-2-positive metastatic breast cancer,NONMEM,Pharmacokinetics,Population pharmacokinetics,Trastuzumab,