Navigation Links
PhRMA Statement Supporting Fair Incentives for Biologics Innovation
Date:10/19/2009

have the potential to circumvent patents -- while qualifying for an abbreviated application.

"Economists and the venture capitalists whose private investments shore up this vital, yet vulnerable sector agree: 12 years of data protection, at a bare minimum, are needed to help recoup the significant development costs for biologic innovators. That, however, does not constitute market exclusivity. Companies could still seek approval of competing biologics using their own data, but for those 12 years no biosimilar competitor could rely on innovators' hard-earned data, collected during development that may span a decade, or more, to seek approval.

"For many biologics on the market right now, the 12-year data protection clock began ticking long ago, when federal regulators approved the therapy. In addition to the brand-to-brand competition that already occurs for biologics, those biologic medicines could face biosimilar competitors relatively soon; multiple biosimilars are already on the market in Europe.

"Biosimilar versions of current biologics may well be approved before 12 years have elapsed after the law's enactment, but 12 years of data protection is important to provide incentives for manufacturers to create the next wave of innovative biologics.

"Giving short shrift to incentives for innovation would grind to a halt uniquely American innovation, moving critically important R&D -- and tens of thousands of U.S. jobs -- overseas. Right now, 80 percent of the world's biotech research occurs in the U.S.

"A diverse group of supporters agree with the need for adequate data protection, from patients eagerly awaiting new therapies to elected officials who understand how tenuous U.S. leadership in biologics research could become if incentives for innovation are weakened:

  • 'Many of these biologics will be developed from early-stage discoveries arising from basic research conducted by universities. ..
    '/>"/>

SOURCE Pharmaceutical Research and Manufacturers of America
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. PhRMA Statement on Senate Finance Committee Vote
2. Amgen Issues Statement on Outcomes of Advisory Committee for Reproductive Health Drugs (ACRHD) Meeting
3. SCAI Statement on the BARI 2D Trial (Bypass Angioplasty Revascularization Investigation With Diabetes Trial) Presented at the American Diabetes Association (ADA) Annual Scientific Sessions and Published in The New England Journal of Medicine
4. EAU Position Statement on Screening for Prostate Cancer
5. Joint Statement from the American Diabetes Association and American Association of Clinical Endocrinologists on the NICE-SUGAR Study on Intensive Versus Conventional Glucose Control in Critically Ill Patients
6. A Joint Statement From Americas Prostate Cancer Advocacy, Education, and Support Organizations
7. Coalition for 21st Century Medicine Issues Statement in Opposition of Genentech Petition to Restrict Lab Use of Diagnostic Tests for Physicians and Patients
8. American Heart Association Scientific Statement: Heart Patients Should Be Screened, Treated for Depression
9. Deer Farm Industry in Michigan Issues Statement on the Negative CWD Test Results at Kent County Deer Farm
10. VA Statement on Smoking Cessation Research Program
11. Statement From the Lupus Foundation of America Regarding the Release of Top-Line Results From a Study of Rituxan for the Treatment of Lupus
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/27/2015)... VEGAS , Aug. 27, 2015 The nation,s ... in a Las Vegas courtroom.  Attorneys ... argue the men suffered severe effects, including death, after using ... our clients what they as a company knew, that their ... attorney Robert Eglet .  "In order to hold Takeda ...
(Date:8/27/2015)... -- BioElectronics Corporation (OTC Pink: BIEL), the maker of advanced ... the use of ActiPatch®, its novel musculoskeletal pain therapy, ... of the European Pain Federation EFIC®, Vienna, ... Company will also be exhibiting at the Congress in ... department clinical and experimental rheumatology from the University of ...
(Date:8/27/2015)... HARRISBURG, Pa. , Aug. 27, 2015  PinnacleHealth CardioVascular ... and second in the United States ... a new type of stent for blockages in the main ... flexibility within the artery and potentially less risk for stent ... MIMICS-2 is a prospective, single-arm, multicenter clinical trial of the ...
Breaking Medicine Technology:2 Billion Dollar Verdict Sought In Actos Trial 2BioElectronics Selected to Present its Pain Research and Devices at the European Pain Federation Conference 2First Pennsylvania Patient Treated in Landmark Vascular Study 2
... MediSensors, Inc. ( www.c8medisensors.com ), the leader in developing ... today that it has filed for CE mark approval ... Europe. The monitor is currently an adjunct investigational device. ... "The European Union has over 30 million people with ...
... 2012 /PRNewswire-Asia-FirstCall/ -- American Oriental Bioengineering, Inc. (NYSE: ... Stock Exchange (the "NYSE") has notified the Company that it ... Company,s failure to timely file its Annual Report on Form ... Under NYSE rules, when a Company does not comply with ...
Cached Medicine Technology:C8 MediSensors Files for CE Mark Approval, Advancing Plans for 2012 Product Introduction In Europe 2American Oriental Bioengineering Inc. Receives NYSE Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard 2
(Date:8/27/2015)... ... 27, 2015 , ... In the addiction treatment industry, some patients go through ... and returning again, all at great cost to them and their families. Others have ... soon after leaving facilities who claim to have given addicts tools to overcome their ...
(Date:8/27/2015)... ... August 27, 2015 , ... In an article ... situation in the city of New Orleans, highlighting a security firm that is tasked ... by a tech oriented entrepreneur who worked with the city to provide private security ...
(Date:8/27/2015)... , ... August 27, 2015 , ... ... years after Hurricane Katrina slammed into the Gulf Coast, killing more than 1,800 ... $100 billion, according to a Georgia State University study. , While most people ...
(Date:8/27/2015)... ... 27, 2015 , ... Healthpointe is proud to welcome Dr. Ted Priebe, O.M.D., ... Licensed to practice Chinese Needle Therapy since 1983, Dr. Priebe specializes in the study ... also practices in Healthpointe’s La Mirada clinic and Garden Grove clinic. , ...
(Date:8/27/2015)... ... August 27, 2015 , ... ... company and leading biopharmaceutical contract development manufacturing company (CDMO), announced today that it ... (“Hepalink”) for $205.68M in cash. , The addition of Cytovance Biologics ...
Breaking Medicine News(10 mins):Health News:National Screenings of Documentary Indicate Burgeoning Questions about the Effectiveness of Addiction Treatment Facilities 2Health News:National Screenings of Documentary Indicate Burgeoning Questions about the Effectiveness of Addiction Treatment Facilities 3Health News:Article on New Orleans Security Force Highlights the Abilities and Flexibility of Private Security, says Spear Security Inc. 2Health News:About 10 Percent of Mothers Experienced Depression Two Years After Hurricane Katrina, New Study Shows 2Health News:Qualified Medical Examiner and Acupuncturist Joins Healthpointe in Los Angeles 2Health News:Qualified Medical Examiner and Acupuncturist Joins Healthpointe in Los Angeles 3Health News:Great Point Partners, LLC Announces that Hepalink USA Inc. Agrees to Acquire Cytovance Biologics, Inc. 2Health News:Great Point Partners, LLC Announces that Hepalink USA Inc. Agrees to Acquire Cytovance Biologics, Inc. 3Health News:Great Point Partners, LLC Announces that Hepalink USA Inc. Agrees to Acquire Cytovance Biologics, Inc. 4
... of a naturally occurring fat molecule have the potential ... or damage, researchers report. , Through both the ... smooth, young skin inevitably becomes coarse and wrinkled. The ... both lower the production of new collagen while increasing ...
... percent of patients who recently underwent liver transplantation ... factors included having had biliary-enteric anastomosis (choledocho-jejunal or ... more than four red blood cell units transfused. ... of Liver Transplantation, a journal by John Wiley ...
... internet pharmacies and life-saving medicines, purchased online was ... Global Forum ... June 5 The European Alliance for Access ... research report,-- The Counterfeiting Superhighway. The report revealed ...
... Reps. Pomeroy, Capito, Berkley Leading,Respective Chambers, Letter Effort ... to Seniors, Medicare-Financed Nursing Home Care, WASHINGTON, ... and Alliance for Quality Nursing Home Care today ... and Reps. Earl,Pomeroy (D-ND), Shelley Moore Capito (R-WV) ...
... June 5 Fort Dodge Animal Health, a,division of ... of,ProHeart(R) 6, a unique heartworm preventative, to the U.S. ... Food and Drug,Administration,s Center for Veterinary Medicine (CVM) of ... support the decision,to return this life-saving product to the ...
... to restore function to a paralyzed limb? Or to ... are two of the several topics that will be ... by Case Western Reserve University. The conference will be ... Conference Center in Cleveland. , "Neural interfaces have already ...
Cached Medicine News:Health News:Researchers determine risk factors for infection after liver transplantation 2Health News:Death on the Net? Over 60% of Medicines Sold by Online Pharmacies are Fake 2Health News:Death on the Net? Over 60% of Medicines Sold by Online Pharmacies are Fake 3Health News:AHCA, Alliance Praise New Bipartisan, Bi-Cameral Effort Urging Bush Administration to Forego Medicare Cuts 2Health News:AHCA, Alliance Praise New Bipartisan, Bi-Cameral Effort Urging Bush Administration to Forego Medicare Cuts 3Health News:Fort Dodge Animal Health Announces Reintroduction of ProHeart 6 to the U.S. Veterinary Market 2Health News:Fort Dodge Animal Health Announces Reintroduction of ProHeart 6 to the U.S. Veterinary Market 3Health News:Fort Dodge Animal Health Announces Reintroduction of ProHeart 6 to the U.S. Veterinary Market 4Health News:Fort Dodge Animal Health Announces Reintroduction of ProHeart 6 to the U.S. Veterinary Market 5Health News:Premier conference on neurotechnology and deep brain stimulation to be held in Cleveland June 16-18 2
...
Ascent Primary Knee System with cruciate retaining, posterior stabilized and constrained components...
... Consensus knee system continues the "Consensus Concept" ... with the diversified experience of a Scientific ... knee system that incorporates state-of-the-art features. Consensus ... joint and implant stability and allow near ...
Profix total knee system is intended for cemented use only....
Medicine Products: