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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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.
Amgen Exec Backs WHO’s ‘Biological Qualifier’, Says First Ones Could Be Issued By End Of 2017
An Amgen executive says that the WHO should press ahead with its “biological qualifier” proposal, and suggests that the first BQs could be issued towards the end of 2017.
WHO To Pilot ‘Biological Qualifier’ Scheme Despite Protests From Biosimilars Industry
The World Health Organization has decided to pursue its “Biological Qualifier” scheme despite concerns that it may conflict with other traceability systems. Calls by the European biosimilars industry to put the scheme on ice appear to have fallen on deaf ears.