Regulatory Decision Summary for Semglee
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
Product type:
Summary of Cancellation for Semglee (Control number 202772)
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
Overview
Decision issued
No decision was issued by Health Canada. The company cancelled the submission before a final decision was issued.
Date of cancellation
February 15, 2019
What was the purpose of this submission?
The purpose of this New Drug Submission (NDS) was to seek authorization for Semglee (insulin glargine) as a biosimilar to the Canadian authorized reference product, Lantus (insulin glargine). Lantus is a recombinant human insulin analog indicated for once-daily subcutaneous administration in the treatment of patients over 17 years of age with type 1 or type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia. Lantus is also indicated in the treatment of pediatric patients (>6 years old) with type 1 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia.
What did the company submit to support its submission?
The sponsor submitted clinical data investigating Semglee and Lantus in patients with type 1 or type 2 diabetes. The sponsor also submitted a chemistry and manufacturing data package that met the filing requirements for a biosimilar NDS as outlined in the Health Canada Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs.
Following the initial review of the NDS, a Notice of Deficiency (NOD) was issued by Health Canada on December 20, 2017. A response to the NOD was accepted for review on April 30, 2018.
What was the status of the submission when it was cancelled? What was Health Canadas assessment of the submission at the time of cancellation?
At the time of the cancellation, Health Canada had completed the assessment of the data provided in response to the NOD. Health Canada identified that the clinical data submitted in the response to the NOD were inadequate to address the concerns identified in the NOD. With respect to the chemistry and manufacturing data, the proposed control strategy was not suitable to assess the quality of either the Drug Substance or Drug Product and the biosimilarity of Semglee to the reference product. The sponsor chose to cancel the submission without prejudice to refiling.
What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
The cancellation does not impact the Special Access Programme or clinical trials.
Additional information
Proposed Brand Name:
Semglee