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.
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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.
US FDA Program Streamlining COVID-19 Treatment Development Still Working As Emergency Ends
Any program changes would not occur until after a thorough assessment, the agency said.
Sarepta’s DMD Gene Therapy Adcomm Likely To Focus On Dystrophin As A Surrogate Endpoint
Cellular, Tissue and Gene Therapies Advisory Committee will weigh whether the increase in dystrophin production seen with SRP-9001 is reasonably likely to predict clinical benefit in Duchenne muscular dystrophy, Sarepta says; agency had previously told the company a panel meeting would not be needed, but it reversed course late in the review.