Regulatory Decision Summary for Kanjinti
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:
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Type of submission:
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What was the purpose of this submission?
Kanjinti, a biosimilar to Herceptin (trastuzumab), is approved in Canada in a 420 mg multi-dose vial presentation. This Supplement to a New Drug Submission (SNDS) was filed to add a new 150 mg single-dose vial presentation.
Why was the decision issued?
This new drug product presentation did not require any new clinical trials or extensive data to be provided given the following:
- The new presentations (150 mg) is manufactured at the same manufacturing site as the approved 420 mg multi-dose vial presentation;
- There were no significant changes to the chemical, biological and immunological requirements for batch release;
- The formulation, dosage form, and route of administration have not changed;
- A comparability assessment demonstrated that product manufactured after implementation of the change was comparable to the product manufactured before the change.
The review focused on ensuring that the product in the new presentation was equivalent in quality to the currently approved one and that the data supporting the updated manufacturing processes were satisfactory.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations as per the Notice of Compliance with Conditions Guidance.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| KANJINTI | 02518244 | AMGEN CANADA INC | TRASTUZUMAB 150 MG / VIAL |