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all copies of both published and unpublished clinical studies,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
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
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.
* With assistance from Laura Sigurdson, Articling Student.
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