FDA’s Prefix Solution On Biologic Names Draws Fire
Agency’s nomenclature decisions on Teva’s tbo-filgrastim, Genentech’s ado-trastuzumab emtansine have only added to confusion among products, representatives from the American Society of Health-System Pharmacists and World Health Organization said.
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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.
The CDC panel’s mandate is to make recommendations for each specific vaccine brought forward, not ‘comparing two, three or four vaccines, and coming up with specific recommendations for each one independent of the other,’ chairman Jose Romero says as ACIP recommends use of Janssen’s COVID-19 vaccine under EUA.