GPhA Resorts To Citizen Petition On Biosimilar Naming
This article was originally published in The Pink Sheet Daily
Executive Summary
Trade group argues that if unique names will be required for biosimilars then they also should be required of innovator products following a manufacturing change that is approved based on comparability testing.
You may also be interested in...
FDA Claims Sole Authority Over Naming Of US-Licensed Biologics
Deferring to nonproprietary names established by US Pharmacopeia without exercising independent judgment ‘would be untenable,’ FDA says in citizen petition response to industry; agency offers statutory defense of decision to require distinguishable suffixes for all novel biologics and biosimilars.
FDA Claims Sole Authority Over Naming Of US-Licensed Biologics
Deferring to nonproprietary names established by US Pharmacopeia without exercising independent judgment ‘would be untenable,’ FDA says in citizen petition response to industry; agency offers statutory defense of decision to require distinguishable suffixes for all novel biologics and biosimilars.
Track-and-Trace Bill Clears House With New Electronic Labeling Language
Safeguarding America’s Pharmaceuticals Act passes on suspension calendar, but likely sets up fight with Senate in conference.