FDA Wants Biosimilar Naming Guidance Released Before Approving An Application
This article was originally published in The Pink Sheet Daily
The agency’s policy, planning and legislation chief says FDA hopes a draft guidance is released before the first application is reviewed.
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The generic specialty injectables firm expects to file a biosimilar version of Amgen’s Epogen in the U.S. in late 2014, potentially positioning it for its first U.S. biosimilar launch in late 2015.
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.