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.
Ranking member Tom Davis, R-Virginia, argued that the complexity of biotech drugs makes it essential that would-be generic biotech makers be required to conduct clinical trials of their products.

A vice president from Denmark-based Novo Nordisk, a biotech company that makes diabetes therapies, agreed. Nordisk's Inger Mollerup said that if Congress creates a system to approve cheaper protein-based drugs it should be similar to one already used by the European Union.

Under the EU system, generic biotech companies have to conduct extensive studies to show the safety of their versions. Even after these studies are completed and the product is approved, knockoff biotech drugs are not considered interchangeable with the original product, meaning a patient has to get doctor approval before switching from the original drug to a generic.

Source-Bio-Bio Technology
'"/>




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:


(Date:6/25/2016)... ... 2016 , ... Conventional wisdom preaches the benefits of moderation, whether it’s a ... the bar too high can result in disappointment, perhaps even self-loathing. However, those who ... , Research from PsychTests.com reveals that behind the tendency to set ...
(Date:6/24/2016)... ... ... was in a crisis. Her son James, eight, was out of control. Prone to extreme ... “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If there was ... other children and say he was going to kill them. If we were driving ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Comfort Keepers® of ... Cancer Society and the Road To Recovery® program to drive cancer patients to and ... other adults to ensure the highest quality of life and ongoing independence. Getting ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Haute Beauty Network, affiliated ... Weintraub as a prominent plastic surgeon and the network’s newest partner. , ... most handsome men, look naturally attractive. Plastic surgery should be invisible.” He stands ...
(Date:6/24/2016)... ... June 24, 2016 , ... Venture Construction Group (VCG) sponsors Luke’s ... June 20th at the Woodmont Country Club at 1201 Rockville Pike, Rockville, Maryland, 20852. ... helping service members that have been wounded in battle and their families. Venture Construction ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... -- According to a new market research ... Safety Pen Needles), Needle Length (4mm, 5mm, 6mm, 8mm, ... Purchase (Retail, Non-Retail) - Trends & Global Forecasts to ... for the forecast period of 2016 to 2021. This ... 2021 from USD 1.65 Billion in 2016, growing at ...
(Date:6/23/2016)... HOUSTON , June 23, 2016  MedSource ... platform as its e-clinical software solution of choice.  ... the best possible value to their clients by ... nowEDC.  The preferred relationship establishes nowEDC as the ... pricing for MedSource,s full-service clients.  "nowEDC has long ...
(Date:6/23/2016)...  In a startling report released today, National Safety Council ... a comprehensive, proven plan to eliminate prescription opioid overdoses. ... states are tackling the worst drug crisis in recorded U.S. history, ... Kentucky , New Mexico , ... the 28 failing states, three – Michigan , ...
Breaking Medicine Technology: