FDA re­vers­es course, de­cides not to add suf­fix­es to old­er bi­o­log­ics’ non­pro­pri­etary names

The FDA has de­cid­ed not to go back and re­name bi­o­log­ics’ non­pro­pri­etary names with non­sense suf­fix­es, as it once said it would, rais­ing ques­tions about the con­fu­sion that will like­ly come from a sub­set of bi­o­log­ics’ and biosim­i­lars’ names con­tain­ing suf­fix­es while an­oth­er sub­set of bi­o­log­ics’ names will not con­tain suf­fix­es.

Since 2015, the FDA has been adding the mean­ing­less suf­fix­es to biosim­i­lars’ non­pro­pri­etary names as part of an ef­fort to im­prove phar­ma­covig­i­lance. And since No­vem­ber 2017, the agency al­so be­gan adding the suf­fix­es to new­ly ap­proved bi­o­log­ics’ names, with the in­ten­tion of go­ing back and adding suf­fix­es to all bi­o­log­ics’ non­pro­pri­etary names.

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