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Diabetes, Obesity, and Metabolism (02/01/2016) Vol. 18, No. 2, P. 159; Ilag, LL; Deeg, MA; Costigan, T

Eli Lilly researchers sought to compare the immunogenicity profiles and potential effects on clinical outcomes of LY2963016 insulin glargine (LY IGlar) and Lantus insulin glargine (IGlar) with identical primary amino acid sequences in patients with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM). Anti-insulin glargine antibodies were measured as percent binding and compared between treatments in 52-week (open-label) and 24-week (double-blind) randomized studies in 535 patients with T1DM and 756 patients with T2DM, respectively, and two subgroups of patients with T2DM: insulin-naïve patients and those reporting pre-study IGlar treatment. According to the data, there were no significant treatment differences for insulin antibody levels, incidence of detectable anti-insulin glargine antibodies, or incidence of treatment-emergent antibody response (TEAR) in patients with T1DM or patients with T2DM. There was a statistically significant difference seen in the overall incidence of detectable antibodies, although not at endpoint nor in TEAR for the subgroup of T2DM patients who had received prior IGlar treatment. Both treatment groups had low insulin antibody levels; however, neither insulin antibody levels nor developing TEAR was linked to clinical outcomes. Based on their findings, the researchers conclude that LY IGlar and IGlar have similar immunogenicity profiles.

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