Track-And-Trace Insufficient For Biosimilar Pharmacovigilance, Brand Companies Say
This article was originally published in The Pink Sheet Daily
Executive Summary
A Johnson & Johnson citizen petition lays out the company’s case for individual non-proprietary names for biologics and each of their biosimilars, citing the risk of inappropriate substitution.
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.
Naming Rights: Biosimilar Influence Efforts Continue Before Products Take The Field
FDA isn’t immune to political pressure, but a group of senators arguing that biosimilars should be given the same International Nonproprietary Name as their branded counterparts will need to make a stronger case than citing the agency’s own previous analysis.