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 Supplemental New Drug Submission for Bambevi (bevacizumab), a biosimilar to the Canadian reference biologic product, Avastin (bevacizumab), was to seek a new indication for Bambevi, in combination with carboplatin and gemcitabine, for the treatment of patients with first recurrence platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancer. This is an authorized indication held by Avastin, which was not requested for Bambevi in the original New Drug Submission.
Why was the decision issued?
Bambevi was developed as a biosimilar to the Canadian reference biologic drug, Avastin. In the original New Drug Submission it was concluded that the biosimilarity of Bambevi to Avastin was established, based on data from comparative quality, non-clinical, pharmacokinetics and clinical efficacy and safety studies. To further support the authorization of Bambevi in the indication of recurrent platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancer, a scientific rationale was provided. Based on the assessment of all the evidence, Bambevi is considered to have a favorable benefit/risk profile for the treatment of first recurrence platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancer, in combination with carboplatin and gemcitabine.
An updated Risk Management Plan (RMP) for Bambevi was reviewed by Health Canada and considered acceptable.
A Notice of Compliance (NOC) was recommended.
For further details about Bambevi, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.
Decision issued
Authorized; issued a Notice of Compliance (NOC) in accordance with the Food and Drug Regulations.