No differences in efficacy and safety of SAR-Lis and Ly-Lis were found in two randomized (1:1), multinational, open-label, controlled, parallel-group, phase 3 studies in people with T1DM (SORELLA 1, 12 months) or T2DM (SORELLA 2, 6 months) on a background of insulin glargine (Lantus®; GLA-100, Sanofi) as basal insulin.8,9 In this study, we report on the immunogenicity profiles of participants from SORELLA 1 and SORELLA 2, and the potential impact of anti-insulin antibodies (AIA) on safety and efficacy in the SAR-Lis and Ly-Lis groups. The gene discussed is INS; the disease is type 1 diabetes mellitus.