Zarxio’s Placeholder Name Hints FDA Wants Generic Feel To Biosimilar Market
Brand firms win with FDA requiring a unique name for biosimilars, but adding suffix will likely group filgrastim products together rather than separate them.
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The use of computer drop-down menus organized by generic name was identified as a source of medication errors in the clinical program, confusing Kadcyla with unconjugated trastuzumab. The solution of adding a three-letter prefix to Kadcyla’s nonproprietary name also seems to be the fix for biosimilars.
Teva is the first company to get FDA approval of a version of Amgen’s Neupogen; one biosimilar expert questions why Teva did not switch its BLA to a biosimilar application when that pathway became available.
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.