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:7/30/2015)... , ... July 30, 2015 , ... OSF Healthcare ... results from the 2015 Most Wired Survey conducted by Hospitals & Health Networks. This ... system owned and operated by The Sisters of the Third Order of St. ...
(Date:7/30/2015)... ... July 30, 2015 , ... The connection between a healthy head of hair and a ... of a full head of hair can have a devastating impact on the daily life ... in the work place, the consequences of hair loss are not to be taken lightly. ...
(Date:7/30/2015)... York, NY (PRWEB) , ... July 30, 2015 ... ... Setria®Glutathione and Sustamine® L-Alanyl-L-Glutamine for people on the go. With no water needed, ... Recovery Chewable as a simple way to get the natural ingredients that may ...
(Date:7/30/2015)... ... July 30, 2015 , ... ... worked to protect victims in San Diego, California’s Gaslamp Quarter Plaza for five ... Gaslamp Quarter Plaza actively monitor the area for any suspicious activity. These cameras ...
(Date:7/30/2015)... (PRWEB) , ... July 30, 2015 , ... ... scientific program at ATA’s 21st Annual Meeting and Tradeshow focused exclusively on telemedicine, ... than 300 cutting-edge health care technology vendors, will take place May 14-17, 2016 ...
Breaking Medicine News(10 mins):Health News:OSF HealthCare Named One of the Most Wired Systems 2Health News:OSF HealthCare Named One of the Most Wired Systems 3Health News:New Study Shows the Link between Hair Restoration and Healthy Self-Image 2Health News:Zaca Life Introduces Recovery Chewable Packets with Setria® Glutathione and Sustamine® L-Alanyl-L-Glutamine 2Health News:Zaca Life Introduces Recovery Chewable Packets with Setria® Glutathione and Sustamine® L-Alanyl-L-Glutamine 3Health News:Zaca Life Introduces Recovery Chewable Packets with Setria® Glutathione and Sustamine® L-Alanyl-L-Glutamine 4Health News:Eyepartner Software Helps Victims in Gaslamp Quarter Plaza 2Health News:Eyepartner Software Helps Victims in Gaslamp Quarter Plaza 3Health News:Presentation Proposals for ATA 2016 are Now Being Accepted Online at ATA2016.com 2Health News:Presentation Proposals for ATA 2016 are Now Being Accepted Online at ATA2016.com 3
... BRITISH COLUMBIA Reports have suggested that sleep problems ... are associated with challenging daytime behaviors. A ... ASD confirms these reports and will support the development ... improve behavior, according to researchers from Autism Speaks, Autism ...
... BRITISH COLUMBIA Minority children often encounter racism in ... often have more symptoms of depression, according to a ... Pediatric Academic Societies (PAS) annual meeting in Vancouver, British ... in their lives," said Lee M. Pachter, DO, ...
... Simplifying Medicaid renewal applications may help families keep ... program, resulting in better medical care, according to ... the Pediatric Academic Societies (PAS) annual meeting in ... shown that literacy-related barriers affect retention in the ...
... development of ulcerative colitis , SATURDAY, May 1 (HealthDay News) ... against ulcerative colitis, a new study finds. , Ulcerative colitis ... lining of the rectum and colon, resulting in abdominal pain, ... diet was rich in oleic acid were far less likely ...
... the voluntary recall include Tylenol, Tylenol Plus, Motrin and ... Consumer Healthcare on Friday recalled more than 40 of ... some of the medications may not meet federal quality ... include Tylenol, Tylenol Plus, Motrin, Zyrtec and Benadryl. These ...
... breast milk of fatty acid that promotes brain development, ... Very premature infants have higher levels of DHA -- ... and development of the brain -- when their breast-feeding ... Researchers say a deficiency in DHA (docosahexaenoic acid) is ...
Cached Medicine News:Health News:Discrimination is associated with depression among minority children 2Health News:Reading level of Medicaid renewal applications often too high 2Health News:Olive Oil May Protect Against Bowel Disease 2Health News:DHA Supplements for Mom Good for Preemies 2
(Date:7/30/2015)... 2015  Tandem Diabetes Care®, Inc. (NASDAQ: ... of the t:slim® and t:flex™ Insulin Pumps, today ... Agreements with Dexcom, Inc. to allow the integration ... Dexcom G5 and G6 continuous glucose monitoring ("CGM") ... platform with Dexcom,s future CGM systems is an ...
(Date:7/30/2015)... July 30, 2015  Amgen (NASDAQ: AMGN ... quarter of 2015. Key results include: , ... quarter of 2014 to $5,370 million, with 6 ... ® (etanercept), Prolia ® (denosumab), Sensipar ... XGEVA ® (denosumab). Unfavorable changes in foreign ...
(Date:7/30/2015)... 2015 Eisai Inc. announced today that regulatory ... States , European Union and Japan ... for eribulin, for the treatment of patients with inoperable ... for advanced or metastatic disease. These ... global Phase 3 clinical trial (Study 309), which met ...
Breaking Medicine Technology:Tandem Diabetes Care Announces Development Agreement with Dexcom for Integration of Future Generation CGM Systems 2Tandem Diabetes Care Announces Development Agreement with Dexcom for Integration of Future Generation CGM Systems 3Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 2Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 3Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 4Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 5Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 6Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 7Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 8Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 9Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 10Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 11Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 12Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 13Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 14Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 15Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 16Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 17Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 18Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 19Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 20Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 21Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 22Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 23Eisai Submits Simultaneous Regulatory Applications for Eribulin in Soft Tissue Sarcoma in the United States, European Union and Japan 2Eisai Submits Simultaneous Regulatory Applications for Eribulin in Soft Tissue Sarcoma in the United States, European Union and Japan 3Eisai Submits Simultaneous Regulatory Applications for Eribulin in Soft Tissue Sarcoma in the United States, European Union and Japan 4Eisai Submits Simultaneous Regulatory Applications for Eribulin in Soft Tissue Sarcoma in the United States, European Union and Japan 5
... (Nasdaq: DCTH ) will host a live webcast ... meeting on May 23, 2012 at 10:00 a.m ET at ... commence at approximately 10:15 a.m ET. To listen ... during or after the event, please visit the Investor Relations ...
... May 21, 2012 InfuSystem Holdings, Inc. (NYSE MKT: ... infusion pumps and related services, today announced that it ... notification to NYSE Amex of the "record date" for ... April 30, 2012 the record date for the Company,s ...
Cached Medicine Technology:Delcath to Webcast Management's Presentation at Annual Meeting of Stockholders 2Delcath to Webcast Management's Presentation at Annual Meeting of Stockholders 3InfuSystem Holdings, Inc. Receives Letter From NYSE MKT Regarding Timely Notice Of Record Date For 2012 Annual Meeting Of Stockholders 2
The Storz Premiere comes as anterior, posterior and anterior/posterior combo. The combo provides the following modes irrigation, irrigation/aspiration, vitrectomy, and illumination....
Multiple Modulation Phaco (MMP) programmability with eight surgeon settings for maximum versatility. The combination of the peristaltic power balanced pump and the piezoelectric handpiece results in ...
Phaco-emulsification systems CV series...
... The SIStem (Solutions ... departs from the traditional. ... perspectives in phaco, with ... totally unique fluidics module, ...
Medicine Products: