Study supports advanced IV preparation and storage of ABP 215

Biosimilars/Research | Posted 07/05/2021 post-comment0 Post your comment

The first approved bevacizumab biosimilar, ABP 215 (Mvasi), can be prepared in bag, over a month prior to being used to treat patients via intravenous (IV) infusion, shows a study published in GaBI Journal [1]. The study reveals that ABP 215 retains physicochemical stability after dilution and storage, which can ease the process of drug administration in clinical settings.

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Bevacizumab is a humanized monoclonal antibody targeting vascular endothelial growth factor A (VEGF-A). It is used for the treatment of various advanced solid tumours including colorectal cancer, non-small cell lung cancer (NSCLC), renal cell cancer and cervical cancer.

Amgen’s ABP 215 bevacizumab biosimilar was approved in the US in 2017 [2] and in the EU in 2018 [3]. It is supplied commercially as a liquid in single-use 25 mg/mL vials. This is then administered by IV infusion after dilution in a pre-filled infusion bag. In many regions globally, IV bags may be routinely prepared at centralized hospital pharmacy locations and then distributed to sites for patient administration. In many cases, the practice of dose banding allows for the advance preparation of specific doses of drugs that have sufficient stability. Now that the extended physicochemical stability of ABP 215 under in-use conditions has been proven, this will enable flexibility in administration, by ensuring efficacy during handling conditions.

To evaluate the extended storage and simulated infusion of ABP 215 in IV bags, two lots of ABP 215 at high- (16.5 mg/mL) and low- (1.4 mg/mL) dose concentrations in two different types of IV bag under ambient light conditions were used. These were stored at 2°C–8°C for 35 days, followed by 30°C for 2 days, and each bag was infused on Day 37. Their subsequent analyses of the solutions revealed that there were no meaningful changes seen in ABP 215 purity. In addition, protein concentration remained consistent throughout the study for all samples and no significant loss in potency was detected. The study did not observe any potentially proteinaceous particles or increases in subvisible particles.

Thus, according to the study, following dilution, extended storage and infusion, ABP 215 exhibited consistent product quality and activity with no significant degradation observed under the conditions tested. This supports the advance preparation and storage of ABP 215 in IV bags for infusion which will enable flexibility in clinical administration.

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References
1. Seckute J, Castellanos I, Bane S. Physicochemical stability of the bevacizumab biosimilar, ABP 215, after preparation and storage in intravenous bags. Generics and Biosimilars Initiative Journal (GaBI Journal). 2020;9(4):155-62. doi:10.5639/gabij.2020.0904.026
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves bevacizumab biosimilar Mvasi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 7]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-bevacizumab-biosimilar-Mvasi 
3. GaBI Online - Generics and Biosimilars Initiative. EC approval for bevacizumab biosimilar Mvasi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 7]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-bevacizumab-biosimilar-Mvasi

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