Regulatory Decision Summary for ADMELOG

HUMALOG is a short acting insulin analogue authorized for the treatment of diabetes mellitus in patients who require insulin for the maintenance of normal glucose homeostasis and for the initial stabilization of diabetes mellitus. HUMALOG has been authorized in Canada since 1996 and has an established favourable benefit/risk profile for the treatment of diabetes mellitus.

To support the similarity of ADMELOG to HUMALOG, the sponsor provided evidence of comparable pharmacokinetic and pharmacodynamic activity of ADMELOG and HUMALOG in adult patients with type 1 diabetes mellitus. Further, two phase III, randomized, active-controlled trials in adult patients with type 1 and type 2 diabetes did not show clinically meaningful differences in safety, efficacy or immunogenicity between ADMELOG and HUMALOG. On the basis of these results, and considering the similarity demonstrated in comparative structural, functional, and non-clinical studies, the totality of data supports the market authorization of ADMELOG for the same indications as HUMALOG (100 units/mL).

As the evidence demonstrated similarity of ADMELOG to HUMALOG, the benefit/risk assessment for ADMELOG is considered positive.

Overall, based on the totality of evidence derived from the comparative structural, analytical and functional, non-clinical and clinical data, similarity between ADMELOG and HUMALOG has been demonstrated.