Bioequivalence and immunogenicity of insulin LisPro biosimilar compared to reference drug

Introduction . Insulin therapy is the only treatment for type 1 DM and one of the options for intensifying the treatment for type 2 DM. The production of own insulin biosimilars will increase patients access to the providing drugs and can potentially reduce medical costs on healthcare for government. Aim . Compare the equivalence of pharmacokinetics (PK) and pharmacodynamics (PD), safety, efficacy, and immunogenicity between insulin biosimilar RinLis®, 100 IU/ml (LLC GEROPHARM, Russia) to original Humalog®, 100 IU/ml (Lilly France, France). Materials and methods . The clinical trial was conducted in two phases. Phase I – randomized double-blind, two-arm crossover study of PK and PD using hyperinsulinemic euglycemic clamp (HEC) method in 28 healthy volunteers (NCT03604575). During HEC regular blood sampling was performed to assess glucose and insulin concentrations. The glucose infusion rate (GIR) was adjusted based on glycemia measurement. These data were used to calculate the PD parameters: the total area under the GIR-time curve (AUC GIR ) and the maximum GIR over the observation period (GIR max ); PK parameters: the total area under the concentration – time curve (AUC ins. ) and the maximum insulin concentration over the HEC (С ins. max ). Phase II – randomized multicenter open-label comparative study in parallel groups with an assessment the frequency of an immune response after 26 weeks of therapy (NCT04023344). The comparability of the studied drugs was considered proven if 90% confidence intervals (CI) for the ratio of geometric means of FC and PD were in the range of 80–125%. Results . In the course of the study, it was revealed that RinLiz® and Humalog® insulin had comparable PK and PD profiles. The ratio of the geometric mean values of the AUC GIR and GIR max were in the range of 80–125% and amounted to 106 [95–118] % and 108 [97–121] %, respectively. The equivalence also was confirmed by the ratio of the geometric mean values of the AUC ins. and С ins. max , which amounted to 91 [86–97] % and 94 [91–97] %. In the second phase of the study after 26 weeks of therapy the frequency of immune response between two groups did not differ. Conclusion . The obtained data have demonstrated the bioequivalence and immunogenicity of RinLiz® insulin to the original Humalog® in terms of PK, PD and safety parameters.

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