The CADTH Releases Submission Guidelines for Biosimilars

On March 7, 2014, the Canadian Agency for Drugs and Technologies in Health (CADTH) released Common Drug Review Procedure and Submission Guidelines for Subsequent Entry Biologics. This document provides an overview of the Common Drug Review (CDR) procedure and submission requirements for biosimilars, which in Canada are known as subsequent entry biologics (SEBs). The procedure and guidelines are applicable to SEBs, which are biologic drugs with a high degree of similarity to a biologic that has already been authorized for marketing in Canada.

A CDR submission for an SEB may be made either after Health Canada has granted a Notice of Compliance (NOC) for the SEB or before an NOC has been issued when it is likely that Health Canada will issue the NOC within 90 calendar days of filing the CDR submission. If the submission is filed before an NOC has been granted, the manufacturer must provide the finalized product monograph and NOC to the CADTH as soon as they become available. The CDR submission must include the following:

  • all copies of both published and unpublished clinical studies, along with any articles and errata relating to the published studies;
     
  • economic and epidemiologic information of the disease(s) or condition(s) for the indication(s) of the SEB;
     
  • pricing and availability information, including the price per smallest unit and the price per smallest dispensable unit for all dosage forms, strengths and packaging forms, as well as information regarding the method of distribution to pharmacies; and
     
  • a letter authorizing unrestricted sharing of information with participating provincial drug plans, health authorities, Health Canada and the Patented Medicine Prices Review Board.

 

The CADTH may request additional information during the review of the CDR submission, either from the drug manufacturer or from Health Canada, such as copies of Health Canada reviewers’ reports, clinical study reports or Periodic Safety Update Reports.

Under the CADTH’s review procedure, its review reports and final recommendations will be published on its website. Manufacturers are provided with the opportunity to review the reports before they are posted on the CADTH website and to request that CADTH remove information that is confidential. CADTH is not subject to the federal Access to Information Act, but has developed confidentiality guidelines that it believes are sufficient to protect the information provided in a CDR submission. It is important for manufacturers to clearly identify information in their submissions that is not publicly available in order to try to mitigate the risk of CADTH disclosing such information.


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* With assistance from Laura Sigurdson, Articling Student.

 

 

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