Navigation Links
Statement from Ralph G. Neas, President and CEO, Generic Pharmaceutical Association, on the Front Page New York Times Story Regarding the Pre-emptive Strikes of Amgen/Genentech to Restrict Access to Affordable and Safe Biosimilars

WASHINGTON, Jan. 29, 2013 /PRNewswire-USNewswire/ --Today's story shines a light on what essentially is a pre-emptive strike by Amgen and Genentech designed to choke the flow of safe and affordable life-saving biologic medicines to patients even before these products have been approved by the Food and Drug and Administration (FDA).  This is unfortunate because it puts profits ahead of the patients who need these treatments but many times cannot get them because of their prohibitively high cost.

The efforts highlighted in the Times story are doubly worrying for state legislators because not only will they slow availability of safe, effective and more affordable therapies to patients, but they also will dramatically decrease the much-needed cost savings that biosimilars will provide. At a time when legislators are desperately seeking ways to keep their state fiscally sound, these bills will encourage needless and wasteful spending on name brand therapies even after FDA-approved lower cost biosimilar products become available.

While in the guise of supporting biosimilar efforts, Amgen and Genentech are making every effort to limit consumer and patient access to safe and effective biosimilars in the future.

Biosimilar medicines, which are less costly versions of brand-name biologics, have been used safely in Europe for nearly seven years.  However, these affordable treatments are not yet available in the U.S.  But under new federal laws, the FDA now is developing regulations that will allow for the approval and use of biosimilars here at home.  Make no mistake: patient safety is paramount both for the FDA and for the companies that will make these medicines.  In fact, many of the companies who are working to develop biosimilars are the same companies now making brand name biologics.

As the Times story correctly notes, efforts by brand companies to erect barriers to competition from lower cost generic versions of their drugs have been going on for decades.  But as is true with traditional prescription drugs, competition from safe, effective and more affordable biosimilars will, in the coming years, provide patients the savings they need while delivering the lifesaving therapy they depend upon.

According to an analysis by IMS Health published August 2, 2012, generic medicines saved the U.S. health care system more than $1 trillion over the past decade, $192 billion in 2011 alone.  We are confident that the use of safe and effective bisimilars will achieve similar savings.

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 80 percent of the prescriptions dispensed in the U.S. but consume just 27 percent of the total drug spending. Additional information is available at

Generic Pharmaceutical Association - 777 Sixth Street, NW, Suite 510 - Washington, D.C. 20001

SOURCE Generic Pharmaceutical Association
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Icahn Issues Statement Regarding Amylin Pharmaceuticals
2. American Society of Hematology Statement on Senate Passage of Prescription Drug User Fee Act (PDUFA)
3. American Society of Hematology Statement on House Passage of Prescription Drug User Fee Act (PDUFA)
4. Millennium Laboratories Wins Lawsuit: Ameritox Advertisements Regarding Rx Guardian and Rx Guardian CD Contain Literally False Statements
5. Statement from the Cystic Fibrosis Foundation on Passage of the EXPERRT Act in House of Representatives
6. Lilly Statement on PDUFA Vote by Senate
7. Statement from the Cystic Fibrosis Foundation on Passage of the EXPERRT Act in the U.S. Senate
8. Lilly Statement on Affordable Care Act Ruling by Supreme Court
9. Statement from Mary Vogt, President of Home Access Health Corporation, manufacturer of the Home Access HIV-1 test system, the only over-the-counter HIV test previously approved by the FDA for at-home use.
10. CRE Statement on "Inherent Reasonableness" for Retail Pharmacy Diabetic Supplies
11. Johnson Health Tech Statement on Lance Armstrong
Post Your Comments:
(Date:6/24/2016)... , June 24, 2016   Bay Area ... Network,s Dean Center for Tick Borne Illness ... and Rehabilitation, MIT Hacking Medicine, University of California, ... today announced the five finalists of Lyme ... disease.  More than 100 scientists, clinicians, researchers, entrepreneurs, ...
(Date:6/24/2016)... The Academy of Managed Care Pharmacy (AMCP) ... would allow biopharmaceutical companies to more easily share health ... and coverage decisions, a move that addresses the growing ... The recommendations address restrictions in the sharing of ... label, a prohibition that hinders decision makers from accessing ...
(Date:6/24/2016)... Research and Markets has announced the addition of ... report to their offering. ... The World Market for Companion Diagnostics covers the world market ... the report includes the following: , World ... Region (N. America, EU, ROW), 2015-2020 , World IVD ...
Breaking Medicine Technology:
(Date:6/27/2016)... Viejo, California (PRWEB) , ... June 27, 2016 , ... ... are fully customizable inside of Final Cut Pro X," said Christina Austin - CEO ... another unique style. Final Cut Pro X users can now reveal the ...
(Date:6/27/2016)... Brooklyn, NY (PRWEB) , ... June 27, 2016 ... ... is using cutting edge technology to revolutionize the emergency ambulance transport experience for ... Many are aware of how Uber has disrupted the taxi industry through the ...
(Date:6/26/2016)... , ... June 26, 2016 , ... On June 10-11, ... of the 2016 Cereal Festival and World’s Longest Breakfast Table in Battle Creek, MI, ... the city’s history as home to some of the world’s leading providers of cereal ...
(Date:6/26/2016)... NC (PRWEB) , ... June 26, 2016 , ... Brent Kasmer, a legally blind and ... to be personalized through a fitness app. The fitness app plans to fix the two ... currently only offer a one size fits all type program , They don’t ...
(Date:6/25/2016)... , ... June 25, 2016 , ... Austin residents seeking ... American College of Mohs Surgery and to Dr. Russell Peckham for medical and surgical ... effective treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by ...
Breaking Medicine News(10 mins):