Navigation Links
FDA Cites Challenges of Generic Biotech

A top drug regulator told lawmakers Monday it could be a decade or more before science is available to safely approve generic versions of biotech drugs // in the way the agency approves knockoffs of traditional drugs.

Food and Drug Administration deputy commissioner Janet Woodcock's testimony could benefit companies such as Amgen Inc. and Genentech Inc, which have never faced generic competition in the U.S. for their products, some of the most complex and expensive on the market.

That lack of competition would change under a bill recently introduced by Rep. Henry Waxman, D-Calif. The bill would task FDA with approving knockoff versions of biotech medicines, many of which cost tens of thousands of dollars for a year's supply.

Waxman, who chairs the House Committee on Oversight, helped launch the generic drug industry more than 20 years ago when he co-wrote legislation allowing generic manufacturers such as Barr Pharmaceutical Inc. and Mylan Laboratories Inc to market cheaper versions of traditional drugs after the originals loose patent protection. Waxman's new legislation would give generic drug makers access to an estimated $12 billion worth of biotech patents that have already expired.

Unlike traditional chemical-based pharmaceuticals, biotech pharmaceuticals are made from living cells and proteins. The biotech industry has long argued that because these proteins are more prone to minor differences when mass produced, it will be more difficult for generic drug companies to safely reproduce them.

Woodcock said that while FDA can currently establish the safety between versions of simple protein-based drugs, it will likely "be a stepwise progression over a decade or so," before the agency can scientifically verify that a knockoff version of a complex biotech drug is similar to the original. Woodcock testified before The House oversight committee along with representatives from the drug industry and consumer groups. '"/>




Page: 1 2

Related medicine news :

1. Ministry Cites Negligence as Cause of Kazakh baby HIV cases
2. Australia Ready to Meet the Challenges of Bird Flu
3. Sexual Health Service Is Under Pressure and Faced With Financial Challenges
4. Abuja Challenges the Government
5. Nurses in South Africa Face Challenges
6. Bangladesh Progressing But Must Yet Face Challenges In Health Sector
7. Fresh Water, HIV Biggest of Indias Six Challenges: Chidambaram
8. New Study Challenges How Regulators Determine Risk
9. Study Challenges Conventional Treatment of Traumatic Brain Injury
10. Generic drug costs remain shackled
11. FDA Approves Indian Generic Drug For AIDS Treatment
Post Your Comments:
*Name:
*Comment:
*Email:
TAG: FDA Cites Challenges Generic Biotech

(Date:12/26/2014)... 2014 Parker & Sons, Inc. ... in heating, cooling and plumbing contractor services throughout ... services in 2014 with regard to air-conditioning systems. ... is known for its incredibly hot summers. Working ... intricacies and details of a wide variety of ...
(Date:12/25/2014)... 2014 The click strand ... strength and durability. Today, the business announces a ... valid until Jan. 30, 2015. , Click strand ... hardwood. BambooFlooringChina.com is a well-known brand in the ... to find a reliable bamboo flooring supplier. , ...
(Date:12/25/2014)... 2014 Product liability lawsuits filed in ... ( http://www.consumerinjurylawyers.com/DePuy/ ) continue to move forward in federal ... issued in the U.S. District Court, Northern District of ... open conference on January 7, 2015, at the Paul ... West Palm Beach, Florida. The Conference is scheduled to ...
(Date:12/25/2014)... Recently, Dylan Queen, a famous online company supplying ... of discounted prom dresses, most of which are priced ... the company, the promotion is valid until Jan. 22, ... the UK market. , The prom dresses in this ... styles: A-line strapless, empire strapless chiffon, one shoulder, floor-length, ...
(Date:12/25/2014)... sells many bamboo products and the business is famous ... announces big discounts on its bamboo mats , which ... the world’s leader in bamboo flooring. According to the ... 2015. , The bamboo mats are made from well-treated ... the bamboo strips for the mats are boiled and ...
Breaking Medicine News(10 mins):Health News:Parker & Sons Announces Record Demand For 24 Hour Emergency Services In 2014 With Regard To Air-Conditioning Systems 2Health News:Parker & Sons Announces Record Demand For 24 Hour Emergency Services In 2014 With Regard To Air-Conditioning Systems 3Health News:BambooFlooringChina.com: click strand woven bamboo flooring promotion valid until Jan. 30, 2015. 2Health News:Federal Court Overseeing DePuy ASR Hip Lawsuit Set to Convene Conference in January, Bernstein Liebhard LLP Reports 2Health News:Federal Court Overseeing DePuy ASR Hip Lawsuit Set to Convene Conference in January, Bernstein Liebhard LLP Reports 3Health News:Dylan Queen: Cheap Prom Dresses for the UK Market 2Health News:Various Styles of Bamboo Mats in Many Colors from BambooFlooringChina.com 2
... to avoid devastating vision injuries, group says , , ... in the United States, about 40,000 people suffer ... Ophthalmology (AAO), which recommends that all athletes wear ... eye-care professional. , Lenses made from polycarbonate materials ...
... may provide protection against heart disease ... and certain cancers, ARLINGTON, ... the recognized ranks of healthful whole grains, according,to an announcement this week ... food labels to bear the whole grain health,claim. This will enable consumers ...
... International,Rescue Committee emergency team members have arrived in ... deployment to the region as the IRC,prepares for ... "Nearly all homes were destroyed in the ... no access to clean drinking water," says the,IRC,s ...
... Facility, CARSON, Calif., May 9 Leiner ... that it has submitted a,proposed agreement with the ... Court in Delaware for approval. The proposed agreement ... and distribution of certain over-the-counter (OTC) drug products ...
... for Iraq and Afghanistan Veterans Gather in Virginia to,Envision ... CHANTILLY, Va., May 9 As the war ... toll climbs above 4,000 and,casualty numbers approach the 30,000 ... on the homefront have organized to help,bereaved families and ...
... of stimulants a fixture of European nightlife, study says , , ... adults in Europe are drinking alcohol and taking drugs for ... people who are regular nightlife-goers. , The results showed ... aged 16 to 35 drink alcohol to increase their chances ...
Cached Medicine News:Health News:Protective Eyewear Key to Sports Safety 2Health News:FDA Approves Health Claim for Brown Rice 2Health News:FDA Approves Health Claim for Brown Rice 3Health News:FDA Approves Health Claim for Brown Rice 4Health News:FDA Approves Health Claim for Brown Rice 5Health News:International Rescue Committee Mobilizes More Emergency Teams for Myanmar; Warns of Massive Health Disaster Unless Aid Reaches Cyclone Survivors Fast 2Health News:Leiner Health Products Submits Proposed Agreement with Department of Justice to U.S. Bankruptcy Court for Approval 2Health News:Leading Veterans Service Organizations Meet Near Washington May 13-15, 2008 2Health News:Leading Veterans Service Organizations Meet Near Washington May 13-15, 2008 3Health News:Leading Veterans Service Organizations Meet Near Washington May 13-15, 2008 4Health News:Young Adults Using Alcohol, Drugs for Better Sex 2
(Date:12/24/2014)...   Assurex Health, a personalized medicine company ... for behavioral health and chronic pain conditions, today ... equity financing from new and existing investors, according ... Chief Executive Officer. The financing will ... Health,s GeneSight ®  products.  GeneSight,s patented ...
(Date:12/24/2014)... SANTA BARBARA, Calif. , Dec. 23, 2014 ... the Junior Doctors, Association of Sierra Leone ... Sierra Leone for the treatment of local ... While a new dedicated Ebola care center was ... Ebola virus, the facility is not available for local Sierra ...
(Date:12/22/2014)... Mass. , Dec. 22, 2014 ... leading manufacturer of innovative dialysis products, announced today ... has cleared its System One™ to perform hemodialysis ... known as home nocturnal hemodialysis. NxStage,s® System One ... by the FDA for this indication. ...
Breaking Medicine Technology:Assurex Health Secures $30 Million Financing Round to Continue Growth in Neuropsychiatric Pharmacogenomics 2Assurex Health Secures $30 Million Financing Round to Continue Growth in Neuropsychiatric Pharmacogenomics 3Assurex Health Secures $30 Million Financing Round to Continue Growth in Neuropsychiatric Pharmacogenomics 4First Ebola Treatment Unit for Local Health Workers Arrives in Sierra Leone 2NxStage Receives FDA Clearance for Home Nocturnal Hemodialysis 2NxStage Receives FDA Clearance for Home Nocturnal Hemodialysis 3
... Lunar DPX Bravo is a SmartBeam platform providing ... of the two most vital clinical sites - ... low radiation dose., ,The full-function DPX Bravo densitometer ... highly compact footprint. You can place it in ...
... consists of the portable AutoPulse Platform, a ... battery pack with a state-of-the-art recharger. ... with weight up to 300 lbs with ... (76 to 130 cm) and chest width ...
... AI6 is an integrated system that will ... you want it. You no longer need ... of arterial inflow with and without reactive ... choose the time for measurements and the ...
... Vascular System combines cutting edge technology with proven ... vascular package available in the US and Canada. ... you to do vascular examinations in the same ... patient waveforms and data in a database. Tests ...
Medicine Products: