Health Canada issues finalised guidance on biosimilars

Biosimilars/News | Posted 13/04/2010 post-comment0

Health Canada has released the finalised version of its Guidance Document on the approval of Subsequent Entry Biologics (SEBs), which is effective as of 5 March 2010.


An SEB is defined as "a biologic drug that enters the market subsequent to a version previously authorized in Canada and with demonstrated similarity to a reference biologic drug.” An SEB relies in part on prior information regarding safety and efficacy, which influences the amount and type of original data required. An SEB is not a "generic biologic".

Some key provisions are presented below:

  • Approval for a SEB is sought by way of a New Drug Submission (NDS) and not via an abbreviated NDS;
  • A SEB will be approved if the submission demonstrates similarity to a reference biologic drug that has been previously approved for sale in Canada. A reference product not authorised for sale in Canada may be used provided that certain criteria are satisfied.
    • Comparator studies must include characterisation studies that are conducted in a side-by-side format;The determination of similarity does not signify that the quality attributes of the two products being compared are identical, nor is it a declaration of pharmaceutical and/or therapeutic equivalence. Instead, a finding of similarity means that the existing knowledge of both products is sufficient to predict that any differences in quality attributes should have no adverse impact on the safety or efficacy of the SEB;
  • A final determination of similarity can include analytical testing, biological assays, and non-clinical and clinical data; however, the majority of evidence should be based on analytical and biological characterisation.
  • A product using a clearly different manufacturing process compared to the reference biologic drug may not be suitable for authorisation as a SEB.
  • A submission for a SEB comparing to an innovative drug may not be filed until six years after the first approval for the innovative drug.


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