Regulatory Decision Summary for Abevmy
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.
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What was the purpose of this submission?
The purpose of this new drug submission was to seek market authorization of the proposed biosimilar, Abevmy (bevacizumab), on the basis of established similarity to the Canadian authorized product Avastin (bevacizumab). The following indications held by the Canadian reference biologic were proposed for Abevmy: 1) metastatic colorectal cancer, 2) locally advanced, recurrent non-small cell lung cancer (NSCLC), 3) platinum-resistant recurrent epithelial ovarian, fallopian tube and primary peritoneal cancer, and 4) malignant glioma.
Why was the decision issued?
Pharmacokinetic similarity of Abevmy to Avastin was demonstrated in a comparative, single dose, three-arm parallel study in 111 healthy adult male subjects. The results demonstrated that the AUC0-t (90% Confidence Interval [CI]) and Cmax ratios of geometric means falling within the HC bioequivalence standard of 80.0%-125.0%.
The comparability in terms of efficacy, safety and immunogenicity between the products was supported by results of a randomized, double-blind, multicenter study to assess the efficacy and safety of Abevmy compared with Avastin, in the first-line treatment of patients with Stage IV non-squamous non-small cell lung cancer. The trial met its primary efficacy endpoint by demonstrating similarity in the Objective Response Rate (ORR). The risk ratio of ORR for Abevmy to Avastin was 0.96 and the 95% CI (0.81, 1.15) was fully contained within the pre-specified acceptance margin (0.73, 1.36). No clinically meaningful differences were identified in the results of the comparative safety or immunogenicity assessment.
Overall, the results of the non-clinical, comparative pharmacokinetic, safety and efficacy, structural, analytical and functional data were adequate to demonstrate the similarity of Abevmy and Avastin.
In accordance with Health Canada’s biosimilar guidance document, a satisfactory scientific rationale was provided to support the authorization of Abevmy for the proposed indications held by the reference product.
A Notice of Compliance was granted.
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 |
|---|---|---|---|
| ABEVMY | 02522160 | BIOSIMILAR COLLABORATIONS IRELAND LIMITED | BEVACIZUMAB 400 MG / 16 ML |
| ABEVMY | 02522179 | BIOSIMILAR COLLABORATIONS IRELAND LIMITED | BEVACIZUMAB 100 MG / 4 ML |