Navigation Links
Caution Urged on Biologic Drugs

European regulators told a Congressional panel today that some biological drugs -- such as insulin and human growth hormones -- are simple enough// to produce in generic versions, but others are too complex to be safely duplicated.

Generic versions of certain biologics have been allowed in Europe for the last four years, but approval came only after manufacturers conducted rigorous human clinical trials. European regulators recommended today that the United States adopt the same standards.

The testimony came during a Senate Health, Education, Labor and Pensions committee that is considering a bill to permit United States regulators to approve generic versions of biologics, drugs based on living organisms and cells.

Too much flexibility for generic manufacturers in Europe would have “spread suspicion” that the generic biologic products were unsafe, said Nicolas Rossignol, who is responsible for implementing the European Commission’s legislation governing generic biologics. Rossignol testified from Brussels.

Senator Edward M. Kennedy, who chairs the committee, called biologic drugs “miracle medicines” that can come at a steep price to the healthcare system tens to hundreds of thousands of dollars annually per patient. Americans spent an estimated $60 billion on such products last year, according to IMS Health, a healthcare information company, compared with $53 billion in 2005.

Generics that are chemical equivalents to conventional drugs save Americans at least $10 billion per year. The Food and Drug Administration, however, lacks the legal ability to approve generic versions of biologics.

Kennedy, Democrat of Massachusetts, said such legislation should be “led by the science,” while protecting patient safety and valuing the investments made by innovator companies.

Opponents of the current measure, including Senator Orrin Hatch, Republican of Utah, say it lowers safety stan dards and could imperil patients. Hatch cosponsored legislation that speeds to market generic versions of conventional drugs. He favors requiring that prospective generic biologic manufacturers test their drugs in humans before approval. Hatch also supports establishing patient registries to track side effects that may not occur until years after patients start using a product.

“What we need to do is keep working to get the best legislation,” Hatch said.

Source-Bio-Bio Technolog
SRM
'"/>




Related medicine news :

1. Caution On Use of Cholesterol Drugs
2. A Word Of Caution For Tampon Users
3. Taking Vitamin Supplements With Caution
4. WHO Issues Caution Against Bird Flu Epidemic
5. A Word Of Caution: Routine Screening For Breast Cancer Mutation Not Advisdable
6. Cancer Can Recur Any Time, Experts Caution
7. Doctors Do Not Excise Sufficient Caution While Prescribing High-Risk Drugs
8. Teens need to Exercise Caution While Using Online Blogs
9. United Kingdom: Farmers Cautioned To Plan Adequately For Bird-Flu
10. Caution: Apricot Seeds May Be Poisonous
11. Travellers Cautioned Over The Alternate Remedies For Malaria
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:6/27/2016)... ... June 27, 2016 , ... TopConsumerReviews.com recently awarded their highest five-star ... , Millions of individuals in the United States and Canada wear eyeglasses. Once considered ... both correct vision and make a fashion statement. Even celebrities use glasses as a ...
(Date:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet supplements owned by ... to enhance the health of felines. The formula is all-natural and is made from ... the PawPaws Cat Kidney Support Supplement Soft Chews are Astragalus Root Extract ...
(Date:6/25/2016)... Austin, TX (PRWEB) , ... June 25, 2016 , ... ... Fellow of the American College of Mohs Surgery and to Dr. Russell Peckham for ... popular and highly effective treatment for skin cancer. The selective fellowship in Mohs Micrographic ...
(Date:6/25/2016)... ... 2016 , ... As a lifelong Southern Californian, Dr. Omkar Marathe earned his ... David Geffen School of Medicine at UCLA. He trained in Internal Medicine at Scripps ... in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had the opportunity to ...
(Date:6/24/2016)... ... , ... A recent article published June 14 on E Online ... on to state that individuals are now more comfortable seeking to undergo not only ... calf and cheek reduction. The Los Angeles area medical group, Beverly Hills Physicians (BHP) ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... DUBLIN , June 24, 2016 ... addition of the "Structural Electronics 2015-2025: Applications, ... In-Mold Electronics, Smart ... Integrated Photovoltaics Structural electronics involves ... as load-bearing, protective structures, replacing dumb structures such ...
(Date:6/24/2016)... India , June 24, 2016 ... Needles Market by Type (Standard Pen Needles, Safety Pen ... Therapy (Insulin, GLP-1, Growth Hormone), Mode of Purchase (Retail, ... by MarketsandMarkets, This report studies the market for the ... expected to reach USD 2.81 Billion by 2021 from ...
(Date:6/23/2016)... 2016 Research and Markets has announced ... Forecast to 2022" report to their offering. ... the patients with kidney failure, it replaces the function of ... patient,s blood and thus the treatment helps to keep the ... balance. Increasing number of ESRD patients & ...
Breaking Medicine Technology: