Last week the US Food and Drug Administration (“FDA”) provided guidance on the Nonproprietary Naming of Biological Products. Each biologic, whether originator, related product or subsequent entry (biosimilar) will now be given a non-proprietary name comprised of a core
biosimilars
Health Canada releases revised guidance document on approval pathway for biosimilars (formerly “subsequent-entry biologics”)
Summary
Health Canada has revised its guidance document on the approval pathway for biosimilar biologic drugs (biosimilars). The headline change is in the name: Health Canada has retired the “subsequent-entry biologics” moniker. The revised Biosimilars Guidance Document also…