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.
The FDA commissioner also does not want the agency setting goals for rare disease treatment development.
Expedited approval pathway had been a secondary option when traditional approval was not possible, but the CBER director wants surrogate endpoints increasingly considered from the beginning, especially with pediatric rare disease gene therapies.