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biosimilars

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

Photo of Patrick KieransPhoto of Sara Zborovski (CA)Photo of Ian Trimble (CA)
By Patrick Kierans, Sara Zborovski (CA) & Ian Trimble (CA) on January 20, 2017

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…

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

Photo of Christopher A. GuerreiroPhoto of Marie-Hélène Rochon (CA)
By Christopher A. Guerreiro & Marie-Hélène Rochon (CA) on January 11, 2017

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…

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