BIOSIMILARS
By: Eva Furczon, Honours B.Sc., M.Biotech
SUBSEQUENT ENTRY BIOLOGICS IN CANADA:
Noel Courage, B.Sc. (Biochem), LL.B
Introduction:
Canada has approved its first subsequent entry biologic (SEB), Omnitrope® (somatropin). More approvals are expected because many well known biologics are facing patent expiry in the coming years. This short article will provide an overview of biologics, highlight the ongoing developments in the approval pathway of SEBs, as well as explain the patent and regulatory exclusivities available to innovator biologic manufacturers.
14 BIOTECHNOLOGY FOCUS MAY 2011
Competition vs. Exclusivities
