Biosimilar Suffix Naming Idea Trips On Dispensing Problem
American Pharmacists Association tells FDA during biosimilar guidance hearing that using suffixes to create unique names will be problematic. FDA may be leaning toward the unique names, saying published literature indicates adequate safety tracking is not possible without them.
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While FDA may envision suffix selection to be simple, sponsors and branding firms see a much more involved process.
FDA review documents suggest that pharmacovigilence was a significant, but secondary, concern in the naming decision.
Data group says suffix construction FDA will use temporarily for its first biosimilar approval will not ensure Sandoz’s Zarxio and Amgen’s Neupogen are grouped together in provider databases.