FDA revises guidance on biosimilar promotional labels and advertising

Fol­low­ing a re­cent move to ask Con­gress to elim­i­nate the in­ter­change­abil­i­ty des­ig­na­tion for biosim­i­lars, the FDA on Wednes­day pro­posed up­dat­ed guid­ance on the la­bel­ing and ad­ver­tis­ing of bi­o­log­ics and biosim­i­lars.

The new draft of­fers re­quire­ments around the con­tent of pro­mo­tion­al com­mu­ni­ca­tions, and it fol­lows the think­ing around elim­i­nat­ing in­ter­change­abil­i­ty in sev­er­al places, chang­ing up lan­guage and lump­ing biosim­i­lars and in­ter­change­able biosim­i­lars to­geth­er.

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