Canada's New Process For Approval Of Biosimilar Drugs

Law360, New York (May 11, 2010, 12:29 PM EDT) -- Canada has joined Europe, Japan and several other jurisdictions in providing an administrative pathway for approval of “biosimilar” or “follow-on biologic” drugs. These drugs, known in Canada as "Subsequent Entry Biologics" or "SEBs," consist of biological drugs (proteins, antibodies and other products derived from biological sources) which are similar to previously approved biological drugs. Until now, approval of SEBs has been largely stalled, pending clarification as to how such products would be reviewed — to date, only a single SEB has been approved in Canada....
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