Subsequent Entry Biologics (SEBs)— drugs created by a biological process — are demonstratively similar to a previously approved biologic drug but are not exact versions of a referenced products and, as such, are under a different development and regulatory processes from Health Canada.
Marc navigates the differences between SEBs and biologics in terms of their approval process, their equivalency and their commercial viability in various markets.
You can read the full article in the September 2011 issue of the Canadian Pharmaceutical Marketing (CPM).
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