Regulatory Decision Summary for Basaglar

Insulin glargine, marketed as Lantus, can be included as a component of life-saving pharmacotherapy for patients with type 1 diabetes mellitus and is useful in controlling hyperglycemia in patients with type 2 diabetes mellitus. It has been authorized in Canada for over a decade and has proven to be safe and effective in the aforementioned groups of patients and in pediatric (>6 years) patients with type 1 diabetes mellitus. This NDS was submitted to support the authorization of BASAGLAR, a subsequent entry biologic (SEB) to Lantus, on the basis of comparative physicochemical, biological and clinical studies. Clinical studies have demonstrated that BASAGLAR has an acceptable safety profile and is comparable to LANTUS with respect to clinical efficacy in adult patients with type 1 or type 2 diabetes mellitus. In addition, pharmacokinetic and pharmacodynamic comparability has been satisfactorily demonstrated in healthy volunteers. For the remaining indication (pediatric type 1 diabetes mellitus), authorization required extrapolation. Scientific rationales and expert opinion submitted by the sponsor were found to be adequate to support extrapolation to pediatric patients with type 1 diabetes mellitus based on an assessment against the principles of extrapolation as outlined in the Canadian guidance document: Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs)^{Footnote 1}. Therefore, the benefit/risk assessment for BASAGLAR, in each of the requested indications, is considered positive.

For more information on Health Canadas decision, please view the Summary Basis of Decision.