Regulatory Decision Summary for Zirabev
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:
ATC code: L01XC07
Type of submission:
Control number:
What was the purpose of this submission?
Pfizer filed this new drug submission to seek market authorization of the proposed biosimilar, Zirabev (bevacizumab), on the basis of established similarity to the Canadian authorized product Avastin (bevacizumab), for the following indications:
- metastatic colorectal cancer
- locally advanced, recurrent non-small cell lung cancer (NSCLC)
- platinum-resistant recurrent epithelial ovarian, fallopian tube and primary peritoneal cancer, and
- malignant glioma.
Why was the decision issued?
Pharmacokinetic (PK) similarity of Zirabev to Avastin was demonstrated in a randomized, single-dose, comparative clinical trial in healthy male volunteers. The results demonstrated that the 90% Confidence intervals (CI) for the estimated ratio of the AUCT was within the accepted region of 80.0% - 125.0%.
In a randomized, double-blind trial of Zirabev plus paclitaxel-carboplatin versus Avastin plus paclitaxel-carboplatin in patients with advanced NSCLC, no clinically meaningful differences were observed in the efficacy, safety or immunogenicity between the two treatment arms. The trial met its primary efficacy endpoint by demonstrating similarity in the Objective Response Rate (ORR). The 95% CI for the risk ratio (RR) of ORR of Zirabev to Avastin was fully contained within the pre-specified acceptance margin.
Furthermore, in accordance with Health Canadas biosimilar guidance document, a satisfactory scientific rationale was provided to support the authorization of Zirabev for the proposed indications held by the reference product.
The final decision for Zirabev was based on the totality of evidence, including structural, functional, non-clinical, pharmacokinetic and clinical comparisons. A Notice of Compliance (NOC) was recommended.
For more information on Health Canadas decision, please view the Summary Basis of Decision.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| ZIRABEV | 02489430 | PFIZER CANADA ULC | BEVACIZUMAB 100 MG / 4 ML |
| ZIRABEV | 02489449 | PFIZER CANADA ULC | BEVACIZUMAB 400 MG / 16 ML |