FW: Announcement of Hearing-Biologics Price Competition and Innovation (Nov. 2-3)

[Guest guest]

An important proposal, which should help to reduce costs of expensive

biological therapies, such as Rituxan, which can remain expensive when

there are no competing generic brands.

It seems that creating identical genetic versions of biologic drugs is

difficult to do for technical reasons, so this is the workaround: the

proposed faster approval of biosimilar (highly similar) drugs.

Details and how to make comment:

http://edocket.access.gpo.gov/2010/pdf/2010-24853.pdf

Karl

From: FDA NEWS FOR HEALTHCARE PROFESSIONALS

[mailto:NewsHealthCareProfs@...]

Sent: Tuesday, October 05, 2010 2:38 PM

FDA NEWS FOR HEALTHCARE PROFESSIONALS

Subject: Announcement of Hearing-Biologics Price Competition and Innovation

(Nov. 2-3)

U.S. Food and Drug Administration

Office of Special Health Issues

10903 New Hampshire Avenue

Silver Spring, MD 20993

Dear Colleague,

FDA is planning for a two-day public hearing on Nov. 2 - 3, 2010, on the

implementation of the Biologics Price Competition and Innovation (BPCI) Act

of 2009. The hearing will be held from 8:30 a.m. to 4:30 p.m. at the FDA's

White Oak Campus, 10903 New Hampshire Ave., Building 31, room 1503, in

Silver Spring, Md.

The BPCI Act establishes an abbreviated approval pathway for biological

products that are demonstrated to be highly similar (biosimilar) to, or

interchangeable with, an FDA-licensed biological product.

The purpose of the hearing is to receive input on the act's implementation

from the public, health care professionals, health care institutions,

manufacturers of biomedical products, industry and professional

associations, patients and patient associations, third party payers, and

current and prospective biological license application and new drug

application holders.

A Federal Register <http://edocket.access.gpo.gov/2010/pdf/2010-24853.pdf>

notice outlines specific issues for which the agency is seeking comment. The

notice also provides meeting information, instructions for individuals who

wish to present at the meeting, and directions for submitting comments.