Regulatory Decision Summary for Aybintio
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 reference product Avastin (bevacizumab) was first approved in 2005 by Health Canada. The sponsor developed SB8 as a biosimilar biologic product to Avastin seeking the same therapeutic indications of Avastin that are not patent-restricted.
Bevacizumab has been widely used in clinical practice for more than a decade with well-established and characterized pharmacological, efficacy, and safety profiles.
In Canada, Avastin is authorized for use in combination with other chemotherapy to treat certain types of the following cancers: metastatic colorectal cancer (mCRC), locally advanced, metastatic or recurrent Non-small Cell Lung Cancer (NSCLC), platinum-sensitive recurrent epithelial ovarian, fallopian tube and primary peritoneal cancer, platinum-resistant recurrent epithelial ovarian, fallopian tube and primary peritoneal cancer, and malignant glioma (WHO Grade IV) – Glioblastoma.
Why was the decision issued?
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.
To demonstrate similarity in PK, efficacy, safety, and immunogenicity profiles between SB8 and Avastin, the following two clinical studies were conducted:
- Phase I study (SB8-G11-NHV): A randomized, double blind, three-arm, parallel group, single dose study in healthy male subjects
- Phase III study (SB8-G31- NSCLC): A randomized, double-blind, parallel group, multicenter study in patients with metastatic or recurrent non-squamous NSCLC.
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 |
|---|---|---|---|
| AYBINTIO | 02522837 | SAMSUNG BIOEPIS CO., LTD | BEVACIZUMAB 400 MG / 16 ML |
| AYBINTIO | 02522829 | SAMSUNG BIOEPIS CO., LTD | BEVACIZUMAB 100 MG / 4 ML |