Physicochemical stability of a bevacizumab biosimilar in vials and diluted preparations: Implications for hospital practice and inventory management.

Abstract

Biosimilars like Vegzelma can significantly enhance access to biologic therapies and reduce healthcare costs, provided that comprehensive stability data is available. This study aimed to provide extended stability data, allowing hospitals and healthcare professionals to effectively manage drug preparation, minimize wastage, and optimize cost-efficiency. The stability assessments employed in this study included ion exchange chromatography, steric exclusion chromatography, dynamic light scattering, and measurements of pH, density, and osmolality. These assessments focused on the physicochemical stability of the bevacizumab biosimilar (Vegzelma) in vials and polyolefin infusion bags when diluted to concentrations of 1.4 and 16.5mg/mL in 0.9% NaCl and stored at temperatures between 2 to 8°C and at 25°C. Results from stability and sterility assays confirm that when diluted in 0.9% NaCl and stored in polyolefin IV bags, Vegzelma remains stable at the commonly used concentrations of 1.4 and 16.5mg/mL for a 96-hour thermal cycle. For opened vials, the study extends the stability period to 60 days at 2-8°C under light-protected conditions. Unopened vials can be safely stored at room temperature, protected from light, for up to 72hours without compromising the product's integrity. All analyses, particle sizing, ion exchange chromatography, spectral analysis, and thermal denaturation, indicated stable molecular and structural integrity of the bevacizumab, with no observed changes in aggregation, ionic distribution, tertiary structure, or thermodynamic properties. These findings demonstrate the biosimilar's resilience against a 72-hour temperature spike. Pharmacies could use this data for flexible treatment scheduling, advanced preparation for weekends, and holidays, resulting in cost-efficiencies with biosimilars.