Regulatory Decision Summary for Mvasi
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.
Type of submission:
What was the purpose of this submission?
The purpose of this NDS was to support the use of Mvasi, a biosimilar to the reference biologic drug Avastin (bevacizumab), for some of the indications and uses currently held by Avastin in Canada.
Why was the decision issued?
This submission was submitted to support the authorization of Mvasi, a biosimilar to the Canadian authorized reference biologic drug, Avastin. Avastin is currently authorized for the following indications and uses in Canada: locally advanced, metastatic or recurrent non squamous non-small cell lung cancer (NSCLC), metastatic colorectal cancer (mCRC), platinum-resistant recurrent ovarian cancer, platinum-sensitive recurrent ovarian cancer, and recurrent glioblastoma (rGBM). The sponsor originally requested all of the above indications for Mvasi with the exception of the platinum-sensitive recurrent ovarian cancer indication. The platinum-resistant recurrent ovarian cancer indication was subsequently withdrawn due to business decision. Upon review of the data, the rGBM indication was withdrawn following Health Canadas recommendation.
The similarity of Mvasi to Avastin has been established from a quality perspective based on extensive analytical and functional studies and non-clinical studies. From a clinical standpoint, the results of a PK study in healthy volunteers demonstrated PK similarity between Mvasi and Avastin. The 90% confidence intervals (CIs) for the tested parameters were all within the acceptance margins of 80% to 125%. The comparability in terms of efficacy, safety and immunogenicity between the products was further supported by a clinical study conducted in NSCLC patients. The primary efficacy analysis showed that the 95% CI of the risk ratio in objective response rate (ORR) was entirely contained within the pre-defined interval of (0.67 to 1.5). Secondary efficacy comparisons were also supportive of the primary efficacy analysis. Numerical differences in safety were observed between the two products, but they are not considered to be clinically meaningful. In addition, there were no clinically significant differences in anti-drug antibody (ADA) formation between patients treated with Mvasi and Avastin.
Based on the totality of evidence derived from the comparative structural, analytical and functional, non-clinical, PK and clinical data, similarity between Mvasi and Avastin has been demonstrated. To further support the authorization of Mvasi in each of the claimed indications, the sponsor provided a scientific rationale that was in line with Health Canadas biosimilar guidance document. Based on the assessment of all the relevant data provided in the submission, the benefit risk balance of Mvasi is considered favourable for the treatment of locally advanced, metastatic or recurrent non-squamous NSCLC and mCRC.
For more information on Health Canadas decision, please view the Summary Basis of Decision.
Approvedissued Notice of Compliance in accordance with the Food and Drug Regulations.