Biological Product Suffix Submissions Limited To 10 Candidates By US FDA
Increasing cap on number suffixs that sponsors can submit from three to 10 will increase review efficiency, agency says, but evaluation will still stop after finding first acceptable suffix as part of final guidance on distinguishable nonproprietary names for novel biological products and biosimilars.
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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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