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FDA Final Rule Amends Definition of “Biological Product”

Photo of Jeff Wurzburg (US)Photo of Mark Faccenda (US)
By Jeff Wurzburg (US) & Mark Faccenda (US) on March 4, 2020

On February 20, 2020 the U.S. Food and Drug Administration (FDA) published a final rule, revising the regulatory definition of biological products to match the definition Congress agreed to in the Further Consolidated Appropriations Act, 2020.  The changes…

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…

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