New Survey: When Will FDA Approve First Biosimilar/Biogeneric?
Definitions for this survey:
• A biosimilar is a non-substitutable biologic drug whose approval is based, in part, on the safety and efficacy dossier of the corresponding branded drug.
• A biogeneric is a biologic that is fully substitutable by a pharmacist or hospital formulary for the corresponding branded drug.
(Please see #msg-48581353 for provisions of the recently enacted law that empowers the FDA to approve biosimilars and biogenerics.)
Q1: When will FDA approve the first biosimilar? a) 2010 b) 2011 c) 2012 or later d) Never
Q2: When will FDA approve the first biogeneric? a) 2010 b) 2011 c) 2012 or later d) Never