Immunogenicity, efficacy, and safety of biosimilar insulin glargine (Gan & Lee glargine) compared with originator insulin glargine (Lantus®) in patients with type 2 diabetes after 26 weeks' treatment: A randomized open label study

Abstract Aim To evaluate the equivalence of immunogenicity, safety and efficacy of Gan & Lee (GL) Glargine (Basalin®; Gan & Lee Pharmaceutical) with that of the reference product (Lantus®) in adult participants with type 2 diabetes mellitus. Methods This was a phase 3, multicenter, open‐label, equivalence trial conducted across 57 sites. In total, 567 participants with type 2 diabetes mellitus were randomized in a 1:1 ratio to undergo treatment with either GL Glargine or Lantus® for 26 weeks. The primary endpoint was the proportion of participants in each treatment arm who manifested treatment‐induced anti‐insulin antibodies (AIA). Secondary endpoints included efficacy and safety metrics, changes in glycated haemoglobin levels, and a comparative assessment of adverse events. Results were analysed using an equivalence test comparing the limits of the 90% confidence interval (CI) for treatment‐induced AIA development to the prespecified margins. Results The percentages of participants positive for treatment‐induced glycated haemoglobin by week 26 were similar between the GL Glargine (19.2%) and Lantus® (21.3%) treatment groups, with a treatment difference of −2.1 percentage points and a 90% CI (−7.6%, 3.5%) (predefined similarity margins: −10.7%, 10.7%). The difference in glycated haemoglobin was −0.08% (90% CI, −0.23, 0.06). The overall percentage of participants with any treatment‐emergent adverse events was similar between the GL Glargine (80.1%) and Lantus® (81.6%) treatment groups. Conclusions GL Glargine was similar to Lantus® in terms of immunogenicity, efficacy, and safety, based on the current study.