Study of equivalence and comparable immunogenicity of biosimilar insulin aspart in comparison with the registered analogue

Abstract

The increase in the prevalence of diabetes mellitus has accelerated significantly in recent years. The situation has been greatly complicated by the COVID-19 pandemic. On the one hand, diabetes mellitus is a risk factor for a severe course of infection, and on the other hand, COVID-19 increases the risk of developing diabetes mellitus. There remain other negative factors that reduce the effectiveness of measures taken to combat the disease: lack of public awareness about diabetes, its effects and preventive measures, which contributes to low vigilance against the disease and neglect of active prevention of diabetes in order to eliminate correctable risk factors. In turn, this leads to an increase in the number of people with insulin resistance and prediabetes. Another important aspect is the lack of effective continuous glycemic control in many patients with diabetes, which increases the risk of complications and disability later in life. The availability of drugs for treatment, especially insulin, is also a problem that can be solved by developing and introducing biosimilars of original insulin drugs on the pharmaceutical market. An important condition for the possibility of transferring patients to more affordable insulin biosimilars is comparability with the reference insulin at all stages of preclinical and clinical trials, proven in accordance with current ESE recommendations. These include the use of the hyperinsulinemic euglycemic clamp method to evaluate pharmacokinetics and pharmacodynamics, as well as immunogenicity studies.