A biosimilar is a biological medicine highly similar to already approved reference biological medicine. GP40061 – is a biosimilar to reference insulin glargine (RIG). Its similarity to RIG has been proved through head to head analytical, preclinical and euglycemic clamp comparability studies. A comparative safety (immunogenicity) study of insulin biosimilar and reference drug is the last stage of the development program. This study aimed to confirm the similar immunogenicity of the drugs.
This randomized open-label, 26-week clinical trial (NCT02059187) enrolled 180 participants with type 1 diabetes mellitus randomized 1:1 to once-daily GP40061 (n=90) or RIG (n=90). The primary endpoint was frequency of immune response development at 26th week. Secondary endpoints included change of anti-insulin antibody (AIA) concentration at weeks 12 and 26 from baseline (at screening), percentage of participants with neutralizing AIA formation. AIA concentration was assessed via enzyme-linked immunosorbent assay. Neutralizing activity was established via binding of insulin alfa-chain and CD220 receptor. The data was compared with Mann-Whitney U-test or X2-test.
Immune response was detected in 2 patients in GP40061 and in 2 patients in RIG (p=1.000). Change of AIA concentration (IU/ml) at week 12 from baseline was -0.19±2.49 (GP40061) and 1.38±10.98 (RIG) (p=0.399), and -0.02±2.85 (GP40061) and 0.30±4.07 at week 26 (p=0.167). Number of patients with neutralizing AIA formation was 17 (19%) in GP40061 and 15 (17%) in RIG (p=1.000).
GP40061 demonstrated similar immunogenicity to the RIG. Considering the whole development program, the biosimilarity of GP40061 to reference insulin glargine was proved.