The Rules Of The Biosimilar Suffix
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA guidance outlines dos and don’ts for proposing a nonproprietary name suffix for a biosimilar.
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Biologic Product Naming: US FDA Sticks With Suffixes ‘Devoid Of Meaning’
Final guidance adds new factors for biosimilar and innovative sponsors to consider in developing distinguishable suffixes for nonproprietary names but FDA is unswayed by calls for meaningful suffixes derived from license holder’s name; timing of retrospective application to previously approved products remains in question.
Biologic Product Naming: US FDA Sticks With Suffixes ‘Devoid Of Meaning’
Final guidance adds new factors for biosimilar and innovative sponsors to consider in developing distinguishable suffixes for nonproprietary names but FDA is unswayed by calls for meaningful suffixes derived from license holder’s name; timing of retrospective application to previously approved products remains in question.
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