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).
Interested in seeing how Pangaea can keep you on the cutting edge of this developing industry? Learn about our Environmental Reviews or Canadian Critical Paths: Loss of Exclusivity (LOE) services or contact us to set up a consultation.
Tweet
Comments 0
You must log in to leave a comment
Already have an account?
Sign up