Health Canada has released a revised version of the draft
guidance document "Information and Submission Requirements for
Subsequent Entry Biologics."1 The guidance document
outlines the regulatory review process that Health Canada will
implement for a Subsequent Entry Biologic (SEB). Comments on this
draft may be submitted to Health Canada for consideration until May
It is noteworthy that SEB regulation will take place entirely
through guidance documents, not through any amendments to the
Food and Drug Regulations or to the Patented Medicines
(Notice of Compliance) Regulations (PM(NOC) Regulations).
This guidance document is an update of the draft guidance
released by Health Canada on January 30, 2008.2 This
guidance document now reflects comments received by Health Canada
from stakeholders over the past year. The guidance document has
been published concurrently with two notices proposing amendments
to guidance documents for the Data Protection and PM(NOC)
Regulations in view of SEB regulation.
Biologics are drug products derived from biological sources and
include gene therapies, vaccines, antibodies and other therapeutic
products derived through biotechnology. An SEB is defined by Health
Canada as "a biologic product that would enter the market
subsequent to, and similar to, an innovator product authorized for
sale in Canada." The innovator product is termed the
"reference product" because the SEB manufacturer may make
reference to the information contained in an innovator's
biologic drug submission in order to reduce the amount of clinical
data that is included in its own drug submission.
The guidance document indicates that SEBs will be approved
through the existing New Drug Submission pathway under the Food
and Drug Regulations. An SEB will be approved if a submission
demonstrates similarity based on a direct or indirect comparison to
a reference product. In certain circumstances, a manufacturer may
be permitted to use a foreign reference product to demonstrate
similarity between an SEB and a product authorized for sale in
Canada. If a non-Canadian reference product is used, the submission
must clearly explain the link between the reference product and the
product authorized for sale in Canada. The proposed amendments to
the guidance documents state when a comparison to a reference
product will trigger the rights afforded to innovators under the
Data Protection and PM(NOC) regimes.
Details regarding the choice of reference product, determination
of similarity, standards for quality assessment, non-clinical and
clinical requirements and risk management are also discussed in the
guidance document. The guidance document affirms that the
authorization of an SEB is not a declaration of pharmaceutical
and/or therapeutic equivalence to the reference product.
In consultations, Health Canada has clearly stated its intention
to regulate SEB approvals via this guidance document, rather than
by an amendment to the drug submission requirements under the
Food and Drug Regulations. Nor will the government be
amending the PM(NOC) Regulations or the data protection provisions
of the Food and Drug Regulations to deal with SEBs.
Health Canada has indicated that there are SEB submissions
currently under regulatory review and that the review process will
proceed before the draft guidance document is finalized.
Effective September 1, 2016, the Disposition of Surplus Real Property Regulation to the Ontario Education Act was amended with the intention to reduce barriers to the formation of health and community hubs in Ontario.
This appeal relates to two generic drug submissions for two different products: exemestane and infliximab. Both submissions cross-referenced the submission of another generic company that had received a Notice of Compliance.
Two recent decisions from the Supreme Court of Canada directly affect Quebec's farm businesses by confirming La Financière Agricole du Québec's discretion in the administration of the farm income stabilization program...
On October 6, 2016, the Ontario Legislature reintroduced the Patients First Act, 2016 as Bill 41. Bill 41 is very similar to its predecessor, Bill 210, which was introduced in June 2016, but makes some important changes to the previous bill.
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).