On December 2, 2016, Health Canada released its updated guidelines for biosimilar biologic drug submissions. The document will provide guidance to sponsors to enable them to satisfy the information and regulatory requirements for the authorization of biosimilars in Canada.
The following criteria determine the scope if products that are eligible to be authorized as biosimilars:
- a suitable reference biologic drug exists that: a) was originally authorized for sale based on a full quality, non-clinical and clinical data package; and b) has been used in the post market setting such that the demonstration of similarity will bring into relevance a substantial body of reliable data on safety, efficacy and effectiveness
- the biosimilar and reference biologic drug can be well characterized by a set of modern analytical method
- the biosimilar, through extensive characterization and analysis, can be judged similar to the reference biologic drug by meeting an appropriate set of predetermined criteria
For more information, please refer to the December 2, 2016 Guidance Document.