[Ip-health] US FTC To Hold Roundtable On Follow-On Biologics

[Judit Rius Sanjuan]

Note that the FTC will be holding  a roundtable on follow-on biologics
this Friday, November 21, 2008 from 8.30 am to 5 pm

Location: Federal Trade Commission
600 Pennsylvania Avenue, N.W., Room HQ 432
Washington, D.C. 20580

The roundtable will also be webcast.

The agenda is available here: http://www.ftc.gov/bc/workshops/hcbio/agenda/=
fobagenda.pdfSource
:

And Groups that have submitted comments so far: http://www.ftc.gov/os/comme=
nts/healthcarecompissues/index.shtm

# American Medical Association (Maves, Michael ) (9/30/2008)
#537778-00004
# America's Health Insurance Plans (Kanwit, Stephanie) (9/30/2008)
#537778-00003
# Amgen Inc (Beier, David) (9/30/2008) #537778-00011
# Barr Pharmaceuticals (Downey, Bruce) (9/30/2008) #537778-00020
# Bayer Healthcare (Oliver, Sandra) (10/2/2008) #537778-00018
# Biotechnology Industry Organization (BIO) (Taylor, John) (9/30/2008)
#537778-00013
# Coalition for a Competitive Pharmaceutical Market (Huffard, )
(9/30/2008) #537778-00012
# Competition Court of the Basque Country (Spain) (Berasategi, Javier)
(10/2/2008) #537778-00016
# Generic Pharmaceutical Association (Layman, Lisa) (9/30/2008)
#537778-00006
# Hospira, Inc. (Bowman, Lori) (9/30/2008) #537778-00010
# Momenta Pharmaceuticals (Leicher, Bruce) (10/1/2008) #537778-00015
# Novartis (Drake, David) (9/30/2008) #537778-00009
# Pharmaceutical Care Management Association (Jenkins, Missy)
(9/26/2008) #537778-00001
# Pharmaceutical Research and Manufacturers of America (Pritchett,
Anne) (9/30/2008) #537778-00008
# Premier Inc. (Childs, Blair) (9/30/2008) #537778-00007
# Reinhart, Robert (10/19/2008) #537778-00022
# Talecris Biotherapeutics (Bunyan, Bruce ) (9/30/2008) #537778-00019
# Teva Pharmaceuticals USA  (Sanders, David ) (10/8/2008) #537778-00017
# WellPoint (Hall, ) (9/29/2008) #537778-00002
# Wyeth (Eyles, Matt) (9/30/2008) #537778-00005

Source: http://www.pharmalot.com/2008/11/ftc-to-hold-roundtable-on-follow-o=
n-biologics/

FTC To Hold Roundtable On Follow-On Biologics
By Ed Silverman // November 19th, 2008 // 7:19 am

This topic may have fallen off the radar screen amid the presidential
election and the recession, but the rising cost of biologics continues
to be a problem. And the Federal Trade Commission wants to shape the
discussion before Congress and the FDA proceed with a framework that
will permit drugmakers to create and market lower-cost versions.

So, this coming Friday, the FTC will conduct a workshop organized into
five panels to discuss the following issues: the price and market
share effect of entry by both biosimilar and biogeneric drugs, the
likely competitive effects of reference product regulatory
exclusivity, biotechnology patent issues, the likely competitive
effects of follow-on biologic regulatory incentives, and the patent
resolution process.

The FTC, you may recall, wrote a letter in May to the House Energy &
Commerce Committee, saying Congress =93should limit companies=92 ability
to game=85exclusivities at the expense of consumers by (1) disconnecting
the FDA approval process for generic biologics from patent litigation,
and (2) ensuring there is no opportunity for brands effectively to
lengthen their exclusivities through insignificant changes to a
branded biologic product or through excessive procedural delays.=94

Panelists will include luminaries from the FDA, BIO, insurers, generic
and brand-name drugmakers, academia and patent lawyers. This is the
agenda, and these are the public comments filed with the FDA by
various companies and groups over the past several weeks. The
roundtable, by the way, will be webcast. Plan ahead, but we will post
a reminder Friday morning.