Regulatory Decision Summary for Bambevi
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 biosimilar biologic drug, Bambevi (bevacizumab), for use in the treatment of metastatic colorectal cancer, locally advanced or recurrent non-small cell lung cancer, platinum-resistant ovarian, fallopian tube and primary peritoneal cancer, and malignant glioma. The authorization relied on comparative structure and functional, non-clinical and clinical pharmacokinetic, pharmacodynamics, efficacy and safety studies to demonstrate similarity between Bambevi and the Canadian authorized Avastin (bevacizumab).
Why was the decision issued?
The non-clinical data to support the biosimilarity of Bambevi to Avastin included in vivo pharmacodynamic, pharmacokinetic and repeat-dose toxicology studies. Based on an assessment of these studies, no notable biologically significant differences between Bambevi and Avastin with respect to pharmacokinetic, toxicology and toxicokinetic studies we observed. The results support considered to the comparability of Bambevi to Avastin.
Pharmacokinetic (PK) similarity between Bambevi to Avastin was assessed in a randomized, single-dose, comparative clinical trial conducted in healthy male volunteers. The results demonstrated that the 90% confidence intervals (CI) for the estimated ratio of the area under the concentration versus time curve at steady state (AUCT) were within the accepted interval of 80.0% - 125.0%.
Comparative clinical efficacy and safety was supported by a phase 3, randomized, double-blind study conducted in patients with newly diagnosed or recurrent stage IIIB/IV non-squamous non-small cell lung cancer (NSCLC). Patients were randomized to receive either Bambevi plus paclitaxel and carboplatin or Avastin plus paclitaxel and carboplatin. No clinically meaningful differences were observed in the efficacy, safety or immunogenicity between the two treatment arms. The trial met its primary objective of demonstrating similarity in the Objective Response Rate (ORR). The 95% CI for the risk ratio (RR) of ORR for Bambevi to Avastin was fully contained within the pre-specified acceptance interval (0.73, 1.36).
The final decision for this product was based on the totality of evidence, including structural, functional, non-clinical, pharmacokinetic/pharmacodynamic (PK/PD) and clinical comparisons.
For more information on Health Canada’s 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 |
|---|---|---|---|
| BAMBEVI | 02520737 | APOTEX INC | BEVACIZUMAB 400 MG / 16 ML |
| BAMBEVI | 02520729 | APOTEX INC | BEVACIZUMAB 100 MG / 4 ML |