Tag archives: biologics

FDA Final Rule Amends Definition of “Biological Product”

By Rachel Park (US), Jeff Wurzburg (US) and Mark Faccenda (US) on March 3, 2020 Posted in FDA & Food Safety, General

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 reflect the FDA’s efforts to remove regulatory hurdles in order to create cheaper versions of biological products, … Continue reading

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