Background and Importance Several bevacizumab biosimilars are EMA-approved for the treatment of cancer. For each bevacizumab biosimilar, product-specific stability data regarding the concentrated solution and diluted infusion solutions are to be regarded by health care professionals. To our best knowledge, stability information is missing for the concentrated solution of the bevacizumab biosimilar Vegzelma^® (Celltrion) after first opening and prolonged storage.

Aim and Objectives The aim of the study was to investigate the physicochemical stability of bevacizumab 25 mg/mL concentrate (Vegzelma^®) punctured and stored in the original glass vial at two different storage temperatures over a 28-day period.

Material and Methods Three bevacizumab 25 mg/mL vials (Vegelzma^®) each were stored after first opening either light protected at 2–8 °C or at 25 °C for 28 days. Samples were withdrawn on day 0, 1, 7, 14, 21, 28 and analysed with size exclusion chromatography (SEC), ion exchange chromatography (IEC), and dynamic light scattering (DLS). The pH values were measured, and the test vials were visually inspected for visible particles and colour changes at each measuring point.

Results After a 14-day storage period, the quantitative SEC analysis indicated bevacizumab concentrations above 95% of the initial concentration in each test vial. DLS measurements showed no significant variation of the mean hydrodynamic diameter and no appearance of small sized aggregates. IEC analysis revealed no signs of instability. pH values of all samples remained constant, and no visible particles or colour changes were observed.

Conclusion and Relevance Bevacizumab 25 mg/mL concentrate (Vegzelma^®) revealed to be physicochemically stable in the original glass vial after first opening for at least 14 days when stored light protected at 2–8 °C or at 25 °C. Investigations are ongoing until day 28 and presented.

Conflict of Interest Conflict of interest.

Corporate sponsored research or other substantive relationships:

Research grant by Celltrion Healthcare.