Tag archives: biosimilars

Biologics: what’s in a name? Health Canada and EMA take a different approach from FDA

By Sara Zborovski (CA) and Ian Trimble (CA) on January 20, 2017 Posted in Regulatory

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 name and a meaningless four-letter suffix. This is an important divergence from the practice in Canada … Continue reading

Health Canada releases revised guidance document on approval pathway for biosimilars (formerly “subsequent-entry biologics”)

By Christopher Guerreiro (CA) and Marie-Hélène Rochon (CA) on January 11, 2017 Posted in Regulatory

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 contains overhauled guidelines for selecting reference biologics, satisfying the scientific review requirements of the Biologics and Genetic … Continue reading