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:3/24/2017)... ... March 24, 2017 , ... Vighter established its NAEMT Authorized ... providing Prehospital Trauma Life Support (PHTLS) course scholarships to four medics assigned to ... developed in cooperation with the American College of Surgeons to promote critical thinking ...
(Date:3/24/2017)... ... March 24, 2017 , ... ... world countries to hospitals in the United States, it’s a threat that is ... current obstacles facing infection prevention and offers strategies for the healthcare community to ...
(Date:3/24/2017)... Farifax, VA (PRWEB) , ... March 24, 2017 , ... ... its 2017 Quest Awards . The annual awards, now in their 12th year, ... marketing peers selects the winners. , In 2016, the awards were retooled to recognize ...
(Date:3/24/2017)... ... , ... Texas Physical Therapy Specialists (TexPTS) is pleased to announce the ... clinic is the group’s 7th location in San Antonio and 23rd in Texas. ... care from the clinic, which opened March 22, 2017. , The team ...
(Date:3/24/2017)... ... March 24, 2017 , ... ... related services to families and business owners across eastern Michigan, is connecting with ... families struggling with financial difficulties. , The Oxford/Orion FISH Food Pantry works to ...
Breaking Medicine News(10 mins):
(Date:3/23/2017)... LONDON , March 23, 2017 ... comprehensive research report created through extensive primary research ... research, the report aims to present the analysis ... basis of Procedure (Replacement and Repair); Replacement Procedure ... (TAVR)), Repair By Technique (Surgical Devices, Balloon Valvuloplasty, ...
(Date:3/23/2017)... 23, 2017  The U.S. Food and Drug Administration ... treatment of adults and pediatric patients 12 years and ... who have not received prior chemotherapy. This is the ... form of skin cancer. "While skin cancer ... a rare form called Merkel cell cancer have not ...
(Date:3/23/2017)... SAN DIEGO and VANCOUVER, British ... Inc. (NASDAQ: SPHS ) (the "Company" or ... for the treatment of urological diseases, today announced that ... which evaluated the drug as a focal treatment for ... on March 26, 2017 at the 32 nd ...
Breaking Medicine Technology: