Biotech Values

[DewDiligence]

New survey: When will FDA approve first biosimilar/biogeneric?

Definitions for this survey:

• A biosimilar is a non-substitutable biologic reviewed under a 351(k) submission whose approval for marketing is based, in part, on the safety and efficacy of a “reference” drug that was previously approved under a BLA.

• A biogeneric is a substitutable biologic reviewed under a 351(k) submission whose approval is based, in part, on the safety and efficacy of a “reference” drug that was previously approved under a BLA. A biogeneric may be substituted for the reference drug by a pharmacist or hospital formulary without explicit permission from the prescribing MD.

(Please see #msg-48581353 for provisions of the 2010 law that empowers the FDA to approve biosimilars and biogenerics. Note: Lovenox and Copaxone are not biosimilars or biogenerics, but rather complex mixtures regulated by the FDA as small-molecule drugs.)


Q1: When will FDA approve the first biosimilar?
a) 2012
b) 2013
c) 2014
d) 2015
e) 2016 or later


Q2: When will FDA approve the first biogeneric?
a) 2012
b) 2013
c) 2014
d) 2015
e) 2016 or later


To vote, go to
http://www.investorshub.com/boards/board_surveymenu.asp?board_id=1418
and select survey #139.