Biosimilar Naming Is Challenge For Provider Databases
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.
You may also be interested in...
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.
Demand-related shortages are a relatively new problem, but the FDA maintains their tools can prevent or end them.
FDA Commissioner Robert Califf says mentioning China helps increase congressional support.