RESUMEN
SAR341402 (Insulin aspart Sanofi®) is an insulin aspart biosimilar that can be used for continuous subcutaneous insulin infusion (CSII) in pump systems. The physicochemical stability of SAR341402 for CSII use was evaluated in several in vitro experiments. Insulin aspart products (SAR341402, NovoLog®, NovoRapid®) were filled into pump reservoirs and pumped through Medtronic insulin pumps (MiniMedTM 530G-Model 751, Medtronic, Northridge, CA) and their related infusion sets under simulated stress conditions, including elevated temperature and mechanical agitation on a continuously vibrating platform, up to 13 days. Samples pumped through the infusion sets and retained in reservoirs (non-pumped) were analyzed using suitable analytical methods. All products showed stable insulin aspart content and no unwanted impurities. Minor pH changes were seen in all products but were not considered relevant. A time-dependent increase in high-molecular-weight proteins and largest other insulin aspart impurities was observed for each product but each remained within acceptance limits. Concentrations of phenol and metacresol decreased but remained at levels to ensure preservative efficacy. Samples collected from the infusion sets were clear of visible particles and showed comparable subvisible particle counts. No occlusion events were observed. Leachable profiles from pump and reservoir samples were similar in all product batches. Like NovoLog®/NovoRapid®, SAR341402 demonstrates appropriate physicochemical stability when used in these insulin pump systems.