[Ip-health] Follow-On Biologics Workshop: Impact of Recent Legislative and Regulatory Naming Proposals on Competition

Jamie Love james.love at keionline.org
Wed Nov 13 11:50:17 PST 2013


Follow-On Biologics Workshop: Impact of Recent Legislative and Regulatory
Naming Proposals on Competition

The Federal Trade Commission announces it will hold a workshop to explore
competition issues involving biologic medicines and follow-on biologics. As
described in the Federal Register Notice, the workshop will focus on a few
key issues, inter alia:

The potential impact of state regulations affecting competition.
How regulations, if necessary, might be structured to facilitate
competition while still protecting patient health and safety.
How naming may affect competition.
The experience of other countries with follow-on biologic competition.
The Federal Register Notice poses a series of questions about which the FTC
seeks public comment. The FTC will take these comments into account in its
examination of these topics.

Previous Biologics Workshops and Report:

Nov. 2008 Roundtable: Competition Issues Involving Follow-on Biologic Drugs

June 2009 Report: Follow-on Biologic Drug Competition

Event Details

December 10, 2013
Time: 9am – 5pm


FTC Headquarters, Room 432
600 Pennsylvania Ave, NW
Washington, DC 20580

Press Release (November 8, 2013)
Federal Register Notice (November 8, 2013)
Filing a Public Comment (Deadline March 1, 2014)
Agenda (Coming Soon)
Speaker Biographies (Coming Soon)

Webcast (A live webcast will be available on the day of the event. Bookmark
this page and come back on December 10 to link to the webcast.)

Filing a Comment — Deadline: March 1, 2014

The Commission invites interested persons to submit written comments on
issues related to this workshop. Please see the Federal Register Notice for
a list of questions that the FTC is seeking comments on.

To File Electronically:

To make sure that the Commission considers your online comment, you must
file it at https://ftcpublic.commentworks.com/ftc/biologicsworkshop, by
following the instructions on the web-based form.

To File in Paper Form:

Postal mail addressed to the Commission is subject to delay due to
heightened security screening. As a result, we encourage you to submit your
comments online. If you file your comment on paper, write “Workshop on
Follow-On Biologics: Project No. P131208” on your comment and on the
envelope, and mail or deliver it to the following address:

Federal Trade Commission, Office of the Secretary
Room H-113 (Annex J)
600 Pennsylvania Avenue, NW
Washington, DC 20580

If possible, submit your paper comment to the Commission by courier or
overnight service.

Comments will be posted on this website:

Your comment—including your name and your state—will be placed on the
public record of this proceeding. As a matter of discretion, the Commission
tries to remove individuals’ home contact information from comments before
placing them on the Commission Website.

Because your comment will be made public, you are solely responsible for
making sure that your comment does not include any sensitive personal
information, like anyone’s Social Security number, date of birth, driver’s
license number or other state identification number or foreign country
equivalent, passport number, financial account number, or credit or debit
card number. You are also solely responsible for making sure that your
comment does not include any sensitive health information, like medical
records or other individually identifiable health information. In addition,
do not include any “[t]rade secret or any commercial or financial
information which is obtained from any person and which is privileged or
confidential,” as provided in Section 6(f) of the FTC Act, 15 U.S.C. §
46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not
include competitively sensitive information such as costs, sales
statistics, inventories, formulas, patterns, devices, manufacturing
processes, or customer names.

To Request Confidential Treatment:

If you want the Commission to give your comment confidential treatment, you
must file it in paper form, with a request for confidential treatment, and
you have to follow the procedure explained in FTC Rule 4.9(c), 16 CFR
4.9(c). Your comment will be kept confidential only if the FTC General
Counsel grants your request in accordance with the law and the public

Attending the Workshop

The workshop will be free and open to the public. Pre-registration is
strongly encouraged.  To pre-register, please e-mail your name and
affiliation to biosimilars at ftc.gov. Please arrive at FTC Headquarters a
full hour before the event, and no less than 30 minutes before. Seating is
limited, and seats are available on a first-come, first-served basis.
Pre-registration will not guarantee you a seat should the event reach
capacity. You must have a valid government issued photo ID (government
badge, license, passport, etc.). The security processing will include a
metal detector and X-ray screening of all hand carried items. The visitor’s
entrance is at 6th and Pennsylvania Avenue.

FTC Privacy Policy

For additional information, including routine uses permitted by the Privacy
Act, see the Commission's comprehensive Privacy Policy.

Disability Accommodations

The FTC Headquarters is accessible to people with disabilities. If you need
an accommodation related to a disability, please contact Lara Busby at
lbusby at ftc.gov or 202-326-3388. Such requests should include a detailed
description of the accommodations needed and a way to contact you if we
need more information. Please provide advance notice.

For Additional Information Contact:
Elizabeth Jex
Office of Policy Planning
biosimilars at ftc.gov

James Love.  Knowledge Ecology International
http://www.keionline.org, KEI DC tel: +1.202.332.2670, US Mobile:
+1.202.361.3040, Geneva Mobile: +41.76.413.6584,   twitter.com/jamie_love

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