Physicochemical stability of PF-06439535 (bevacizumab-bvzr; Zirabev^®), a bevacizumab biosimilar, under extended in-use conditions.

ABSTRACT:

Introduction

PF-06439535 (bevacizumab-bvzr; Zirabev^®) is a bevacizumab biosimilar. The stability profile and functional activity of PF-06439535 after dilution for intravenous infusion was evaluated following extended storage conditions.

Methods

PF-06439535 drug product was diluted in 0.9% sodium chloride to produce final concentrations of 1.4 and 16.5 mg/mL of PF-06439535, representing clinically relevant low and high doses for intravenous infusion. Three drug product lots and three infusion bag types (polyolefin, ethylene vinyl acetate, and polyvinyl chloride) were tested. To simulate the potential preparation and administration conditions encountered in a clinical setting, prepared drug solutions were initially stored at 25 ± 5°C for 24 ± 2 h, and then at 5 ± 3°

SUBMITTER: Weiser S 

PROVIDER: S-EPMC10302395 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature