Navigation Links
Generic Biologics – U.S Panel Hearing Draws Mixed Response

There are varied reactions to the U.S panel hearing that cheaper versions of biologic drugs// can be manufactured.

The Senate Health, Education, Labor and Pensions Committee is considering legislation that would give the Food and Drug Administration legal authority to approve alternative versions of expensive biologic drugs after patents expire.

Yet it has drawn both brickbats and accolades from various sections.

Says Jay Siegel, head of research for Johnson & Johnson's biotechnology business: ' You just can't take a molecule that you don't know what it is and market it to the people. It's too risky.'

He opines that rival products also known as follow-on biologics should be put up for extensive clinic studies and post approval studies before approval.

Nicolas Rossignol, who oversees implementation of the European Commission’s legislation on biosimilars, told the panel some biologics like insulin and human growth hormones are fairly simple to produce as generics, but that other more complex biologic drugs cannot be reliably duplicated. In general, European regulators advise caution.

Ajaz Hussain, who oversees biological drugs for Novartis AG's generics unit Sandoz,in contrast says science reveals that follow-on biologics can treat the same conditions as their more expensive counterparts.

'FDA already has the expertise' to review them, he told the panel. 'What you need to do is to empower them to act.'

His feelings are echoed by AARP (representing millions of American seniors, and America's Health Insurance Plans) President Erik Olsen:'A therapy is only helpful to the patient who has access to it.

'Biologics hold great promise for treating serious diseases such as cancer, multiple sclerosis, anemia and rheumatoid arthritis, but when some treatments cost thousands of dollars per dose, many patients cannot afford to fill their prescriptions.

'Science has progressed to t
'"/>




Page: 1 2

Related medicine news :

1. Generic drug costs remain shackled
2. FDA Approves Indian Generic Drug For AIDS Treatment
3. Proper Validation of Generic Drugs Could Save Millions of AIDS Patients
4. AIDS Generic Drugs Approved by FDA for Sale in US
5. HIV Mortality declining in India due to Generic Antiretroviral therapy drugs
6. Generic Drugs Usage In US Can Save $20 Billion – Express Script Surve
7. Generic Products Compete With GlaxoSmithKline
8. ViroPharma Shares Fall As FDA Moves Towards Generic Vancocin
9. Ranbaxy Expands By Acquiring A Generic Company In Belgium
10. First Generic Version of Lexapro permitted by US
11. Dr Reddys Launches Generic Version Of Mercks Proscar Tablets
Post Your Comments:
*Name:
*Comment:
*Email:
TAG: Generic Biologics Panel Hearing Draws Mixed Response

(Date:5/23/2013)... (PRWEB) May 23, 2013 On May 23, ... research and advocacy, commends Salem High School senior Max Merget ... cancer. , According to a Patch.com article, Max ... with anaplastic ependymoma -- a large malignant tumor in the ... He underwent surgery but the tumor came back a year ...
(Date:5/23/2013)... To help members more easily ... pleased to announce integration of its advanced ... new upgrade automatically transfers real-time step data onto ... their company’s team standings, view progress on rewards, ... , Walkingspree also offers an integrated nutritional module ...
(Date:5/23/2013)... South Carolina (PRWEB) May 23, 2013 ... anniversary being in practice. For 25 years, Jeff ... honest legal advice with a focus on personal ... years having worked for insurance companies, he offers clients ... how insurance companies operate, which enables him better serve ...
(Date:5/23/2013)... (PRWEB) May 23, 2013 Canadian ... its Max! Healthy Vending Machines, and that's in sync ... report prepared for the Canada Organic Trade Association (COTA). ... organic food and beverages each year. This makes the ... the world. , As a Canadian leader in ...
(Date:5/23/2013)... Portland, Oregon (PRWEB) May 23, 2013 Better ... touches as it prepares to launch its one of ... Final training of management staff will be completed May 29th, ... Chris and Heather Richardson completed on site training in Portland ... the 29th to complete operational training. , "It really is ...
Breaking Medicine News(10 mins):Health News:Voices Against Brain Cancer Commends Young Man for Raising Money for Brain Cancer Despite Fighting His Own Battle 2Health News:Walkingspree Expands Device Options with Fitbit to Increase Member Engagement in Corporate Wellness Programs 2Health News:Walkingspree Expands Device Options with Fitbit to Increase Member Engagement in Corporate Wellness Programs 3Health News:Ezell Law Firm Celebrates 25 Years in Practice 2Health News:Max! Healthy Vending Machines in Tune with Burgeoning Organic Foods Market 2Health News:Better Life Maids of Portland Oregon Prepares For a Summer of 2013 Launch 2
... Alexandria, VA - The 2011 Annual Meeting & OTO ... and Neck Surgery Foundation (AAO-HNSF), the largest meeting of ... convene September 11-14, 2011 in San Francisco, CA. ... and several hundred instruction course hours for attendees, the ...
... effective in helping patients manage their Type 2 diabetes using ... of Maryland School of Medicine researchers. The study is being ... Care . The study, one of the first to scientifically ... blood sugar control the amount of hemoglobin A1c in ...
... Reporter , FRIDAY, July 29 (HealthDay News) -- The ... it uses to approve and regulate "moderate-risk" medical devices ... a highly anticipated federal report released Friday. Instead, ... process that ensures the devices go through more rigorous ...
... College of Radiology and society of Breast Imaging, two top ... issued a statement on a controversial study published in the ... which claimed that there is no evidence that mammography served ... countries where screening has been implemented. , , The ACR ...
... -- The brains of two of four former Canadian ... associated with concussions, say researchers with the Canadian Sports ... (of the Toronto Argonauts and Hamilton Tiger-Cats) and Jay ... encephalopathy (CTE). Both players suffered repeated concussions during their ...
... July 29 (HealthDay News) -- Excluding children from discussions about ... a new study finds. Parents and medical professionals need ... them in decisions, said the researchers from Dublin, Ireland. ... to 18, at three hospitals and found that the kids ...
Cached Medicine News:Health News:World's largest meeting of ear, nose and throat doctors 2Health News:UM School of Medicine finds that mobile phone technology helps patients manage diabetes 2Health News:Report Urges New Review System for Medical Devices 2Health News:Report Urges New Review System for Medical Devices 3Health News:Concussion Project Finds Disease in Two Autopsied Brains 2Health News:Study Finds Kids Want More Info About Their Hospital Care 2
(Date:5/22/2013)... May 22, 2013  Heska Corporation (NASDAQ: HSKA, "Heska" or ... products, announced today that the Company will present at the ... 2013 at the Le Parker Meridian hotel, 119 W. 56 ... . The presentation is scheduled to begin at 2:15 p.m. ... Heska Heska Corporation (NASDAQ: HSKA - ...
(Date:5/22/2013)... , May 22, 2013 /PRNewswire-iReach/ -- World markets ... with the latest trends and events, companies now ... predict where an industry is headed next, so ... (Photo: http://photos.prnewswire.com/prnh/20130522/CG19099 ) ... market research publisher GlobalData, offer decision makers and ...
(Date:5/22/2013)... Calif. , May 22, 2013   Accuray ... that its management is scheduled to present at the ... York on Thursday, June 6, 2013 at ... webcast of the presentation will be available online from ... http://www.accuray.com/investors . The webcast replay of the ...
Breaking Medicine Technology:Adapt, React, Evolve: Staying Ahead in the Breast Cancer Gene Testing, Solar Energy, and Oil & Gas Markets with Reliable Analytics and Actionable Insights from GlobalData's 700 Market Analysts 2Adapt, React, Evolve: Staying Ahead in the Breast Cancer Gene Testing, Solar Energy, and Oil & Gas Markets with Reliable Analytics and Actionable Insights from GlobalData's 700 Market Analysts 3Adapt, React, Evolve: Staying Ahead in the Breast Cancer Gene Testing, Solar Energy, and Oil & Gas Markets with Reliable Analytics and Actionable Insights from GlobalData's 700 Market Analysts 4
... TOKYO, May 22, 2007 /PRNewswire-FirstCall/ -- Sosei ... the,successful completion of a study of its ... for the treatment of cancer,breakthrough pain. , ... centre, open-label,single dose, cross-over, randomised study of ...
... /PRNewswire/ -- A three-year,follow-up subset analysis presented today ... that the CYPHER(R),Sirolimus-eluting Coronary Stent had results comparable ... and better outcomes,than bare metal stents (BMS) in ... arteries. , The CYPHER(R) Stent results in the ...
Cached Medicine Technology:Sosei Announces Successful Completion of AD 923 Pharmacokinetic,Study in the USA 2Sosei Announces Successful Completion of AD 923 Pharmacokinetic,Study in the USA 3Cypher Sirolimus-Eluting Coronary Stent Had Similar Results to,Bypass Surgery and Better Outcomes Than Bare Metal Stents in,Subgroup Analysis of Diabetic Patients With Multivessel Coronary,Disease 2Cypher Sirolimus-Eluting Coronary Stent Had Similar Results to,Bypass Surgery and Better Outcomes Than Bare Metal Stents in,Subgroup Analysis of Diabetic Patients With Multivessel Coronary,Disease 3Cypher Sirolimus-Eluting Coronary Stent Had Similar Results to,Bypass Surgery and Better Outcomes Than Bare Metal Stents in,Subgroup Analysis of Diabetic Patients With Multivessel Coronary,Disease 4
... Codman Sofwire Cable System, ... fixation including sublaminar interspinous ... facial surgery, sternotomy closure. ... and a complete set ...
Demineralized bone matrix dispensed in a jar. Fibers will be free of foreign matter. Glycerol 70-88% by weight. Calcium content less than 8%....
... Inductive demineralized bone matrix ... and cancellous chips will be ... bone matrix particle size is ... chip particle size is 1 ...
Demineralized Freeze-dried Bone Allograft (DFDBA) processed from cortical bone. Demineralized cortical powder is free of all soft tissue....
Medicine Products: