On March 8, 2010, Health Canada released its final guidance
documents relating to the approval pathway for subsequent entry
biologics (SEBs) in Canada. Notably, the pathway is not set in
regulation, but rather, in guidance document. Such documents,
Health Canada's SEB guidance document acknowledges, are
administrative instruments not having force of law. Alternate
approaches to the principles and practices described in guidance
documents may be acceptable provided they are supported by adequate
Consultations had been ongoing since January 2008, with the
release of the first draft guidance for SEB sponsors. A further
draft was released in March 2009, and in addition, at the same
time, draft amendments were released relating to two other guidance
documents, the Patented Medicines (Notice of Compliance)
Regulations and the Food and Drug Regulations, as
they relate to data protection/data exclusivity.
The final SEB guidance contains a few differences from the March
2009 draft guidance. The most controversial element of the pathway
includes the ability for an SEB sponsor to use a foreign reference
product on which to base its comparability studies, for the purpose
of demonstrating similarity. A foreign version of a reference
product can be used even where the Canadian version has not been
marketed (although there is a requirement that the Canadian version
has been approved by Health Canada). The final guidance clarifies
that an SEB sponsor must name the Canadian-approved product and
must provide evidence that the foreign reference product is a
suitable proxy for the Canadian product. The submission must
confirm that the foreign product is marketed by the same innovator
company or corporate entity that is approved to market the
medicinal ingredient in the same dosage form in Canada.
The guidance documents on Data Protection and the NOC
Regulations have been revised to reflect Health Canada's
application of these regulations to SEBs, and the obligations on
SEB manufacturers to respect these rules. Specifically, the
guidance documents provide that, where the SEB pathway for approval
is followed, the SEB manufacturer will be required to observe the
requirements of both sets of regulations. This is true whether the
reference product is Canadian or a foreign version of a Canadian
product. In either case, pursuing the SEB pathway will amount to a
comparison that triggers the application of both sets of
regulations, to the extent they are applicable.
The SEB guidance contains a new element, in explicitly stating
that in the event that the trials suggest superiority of the SEB
over the reference biologic drug, superiority observed will be
assessed for clinical relevance including its impact on safety. In
the event that the superiority observed is considered clinically
meaningful and/or is associated with increased adverse drug
reactions, the product will not be considered an SEB.
Other changes include a specific requirement that the SEB
product monograph state that the product is an SEB. In particular,
the guidance provides that in the product monograph, a statement
will follow the description of the SEB to indicate that similarity
between the SEB and the reference product was established in
accordance with the Guidance for Sponsors: Information and
Submission Requirements for Subsequent Entry Biologics
The final SEB guidance does not address interchangeability of
SEBs for their innovative counterparts, other than to say that
"Authorization of an SEB is not a declaration of
pharmaceutical or therapeutic equivalence to the reference biologic
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