Regulatory Decision Summary for Trurapi
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:
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
What was the purpose of this submission?
This Supplement to a New Drug Submission (SNDS) seeks the addition of a new presentation of Trurapi (insulin aspart) in a 10 mL vial for continuous subcutaneous insulin infusion (CSII) use in pump systems, and for intravenous (IV) use.
Why was the decision issued?
The biosimilarity of Trurapi and Novorapid was previously established through quality, non-clinical, and clinical data.
Continuous subcutaneous insulin infusion (CSII) pumps provide an alternative method for glycemic control to basal-bolus injection therapy, which brings the benefits of better control of A1C level, and improved quality of life.
No meaningful difference was observed between the number of infusion set occlusions for Trurapi compared to Novolog (the United States reference product) delivered via CSII in Study PDY15083. This, in addition to the biosimilarity data between Trurapi and Novorapid, is supportive of the safety of Trurapi use in CSII pumps.
No clinical data were submitted to support the CSII and intravenous routes of administration of Trurapi, except for the safety study comparing Trurapi and Novolog in CSII pumps. Based on similarity demonstrated through historical biosimilarity data, additional studies using Trurapi CSII pumps or intravenous Trurapi were deemed unnecessary, and the aforementioned routes of administration are recommended for authorization - consistent with the Canadian reference product. Furthermore, sufficient biosimilarity data with subcutaneous use support the extrapolation to intravenous use of Trurapi based on European Medicines Agency (EMA) “Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues”.
Overall, based on the totality of evidence derived from historical biosimilarity data and supportive safety data, the benefit-risk profile of CSII and intravenous Trurapi is considered to be similar to the Canadian reference product insulin aspart (Novorapid), and is favourable for the authorized indication.
Decision issued
Authorized; issued a Notice of Compliance (NOC) in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| TRURAPI | 02529254 | SANOFI-AVENTIS CANADA INC | INSULIN ASPART 100 UNIT / ML |