Navigation Links
Plasma Protein Therapies Not Suitable for Biosimilars
Date:11/12/2010

ANNAPOLIS, Md., Nov. 12, 2010 /PRNewswire/ -- The current science and experience does not support the safety and efficaciousness of a biosimilar pathway for plasma protein therapies. At a public hearing last week, the Plasma Protein Therapeutics Association (PPTA) urged the United States Food and Drug Administration (FDA) to make patient safety its top priority by adopting a global approach in its evaluation of plasma protein therapies for the biosimilars process. The hearing sought to obtain input from stakeholders prior to FDA's implementation of the Biologics Price Competition and Innovation Act of 2009, which was part of the new health care reform law.

Plasma-derived therapies and their recombinant DNA technology analogs, collectively known as plasma protein therapies, treat extremely rare, chronic and life-threatening diseases and disorders, including alpha-1 proteinase inhibitor deficiency, hemophilia and primary immune deficiency diseases. At the FDA hearing, PPTA called for harmonization with European Medicines Agency (EMA) guidelines with regard to therapeutic class exceptions for plasma protein therapies.

Under new U.S. federal law, FDA is empowered to exclude a specific product or an entire therapeutic class from the biosimilars process based on the current science and experience. The new law, however, expressly prohibits FDA from using that same rationale to exempt recombinant proteins, including blood clotting factors used to treat hemophilia and other bleeding disorders. This recombinant protein provision runs counter to the precedent established by the EMA in its 2005 guideline that exempts certain plasma protein therapies, including recombinant blood clotting factors, from the biosimilar process in the European Union. Specifically, if a manufacturer of a biological product is seeking approval as a biosimilar by referencing a brand of immune globulin or blood clotting factor (either plasma-derived or recombinant), the EMA guidelines
'/>"/>

SOURCE Plasma Protein Therapeutics Association (PPTA)
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. PEAK Surgical Introduces PlasmaBlade(TM) Product Line Extensions for Use in General Surgery
2. Octapharma Names Dennis D. Curtin To Lead U.S. Plasma Operations
3. New White Paper Examines Advanced Mycoplasma Tests - How Real-Time PCR Analysis Helps Save Time and Money for Biopharmaceutical Manufacturers
4. Researchers prolong the plasma half-life of biopharmaceutical proteins
5. Norgen Biotek Launches 10 New Kits for the Isolation of High-Quality Circulating Nucleic Acids from Blood, Plasma and Serum
6. Painless plasma jets could replace dentists drill
7. Ruedi Waeger Receives the 2010 Robert W. Reilly Leadership Award from Plasma Protein Therapeutics Association
8. PPTA Urges CMS for Appropriate Hospital Outpatient Reimbursement for Plasma Protein Therapies
9. First Duplex Test for Parvovirus B19 and Hepatitis A Virus Increases Safety of Human Plasma and Plasma Products
10. Protein Research Marketing Insights
11. Researchers write protein nanoarrays using a fountain pen and electric fields
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... January 15, 2014 The Microcompetition with Foreign ... disease. One of these latent viruses is the Epstein Barr ... (RA). Rheumatoid arthritis (RA) is a chronic inflammatory disease that ... study found that RA patients have high concentrations of EBV ...
(Date:1/15/2014)... Freeslate, Inc ., the leading ... Lupin Limited, one of India’s top five pharmaceutical companies, ... System for high throughput solid form screening. ... a wide range of quality, affordable generic and branded ...
(Date:1/14/2014)... Date: Friday, April 11, 2014 , Time: 6 p.m. ... Road, Warrington, Pa. , Details: The Hepatitis B ... a cure for hepatitis B and improving the quality of ... Ball on Friday, April 11 at Warrington Country Club in ...
(Date:1/14/2014)... , Jan. 14, 2014  3D Communications, a leading provider of strategic ... business, and media events in the United States ... associate Virginia Cox , JD, is returning to the firm,s ... Cox re-joins 3D after more than two years of service ...
Breaking Biology Technology:Study: Rheumatoid Arthritis (RA) Patients Have EBV; The CBCD Says this is Consistent with Microcompetition 2Study: Rheumatoid Arthritis (RA) Patients Have EBV; The CBCD Says this is Consistent with Microcompetition 3Lupin Selects Freeslate’s CM Protégé PharmD System to Accelerate Polymorph Screening for Drug Development 2Lupin Selects Freeslate’s CM Protégé PharmD System to Accelerate Polymorph Screening for Drug Development 3Hepatitis B Foundation to Host Annual Crystal Ball Gala 2Former FDA Associate Commissioner Returns To 3D Communications 2
... of enzymes routinely used to synthesizing some of nature's most ... new way to expand on nature's chemical creativity to make ... 1) in the journal Science , a team led ... the University of Wisconsin-Madison , describes the discovery of ...
... the new darling of Wall Street. In the past ... private equity firms, venture capital firms, and hedge funds. ... trading multiples in excess of $5 per gallon of ... EBITDA, and 1,000x trailing four quarters of net income. ...
... - When it comes to attracting venture capital, Wisconsin has ... Investors on the East and West coasts have basically stuck ... in the Heartland, with the exception of a few states ... have been signs that a few flights ferrying venture capitalists ...
Cached Biology Technology:UW finds new path to anti-cancer agents 2UW finds new path to anti-cancer agents 3Ethanol producers are at a crossroads 2Ethanol producers are at a crossroads 3Ethanol producers are at a crossroads 4Ethanol producers are at a crossroads 5Ethanol producers are at a crossroads 6That blip on the national venture capital radar screen may be Wisconsin 2That blip on the national venture capital radar screen may be Wisconsin 3
(Date:4/17/2014)... N.M. A credit-card-sized anthrax detection cartridge developed at ... business makes testing safer, easier, faster and cheaper. ... anthrax, is commonly found in soils all over the ... in both humans and animals. The bacteria can survive ... B. anthracis may occur through skin contact, ...
(Date:4/17/2014)... in German . ... they also provide us with a continuous stream of information ... or sit still in a car the world glides ... retinas. Seemingly without effort, our brain calculates self-motion from this ... and a steady gaze during our own movements. Together with ...
(Date:4/17/2014)... hydrogen sulfide in order to properly multiply and form ... Center for Craniofacial Molecular Biology at the Herman Ostrow ... principal investigator on the project, said the presence of ... of calcium ions. The essential ions activate a chain ... creation of new bone tissue, and keeps the breakdown ...
Breaking Biology News(10 mins):Pocket-sized anthrax detector aids global agriculture 2Pocket-sized anthrax detector aids global agriculture 3How vision makes sure that little fish do not get carried away 2How vision makes sure that little fish do not get carried away 3How vision makes sure that little fish do not get carried away 4
... it may sound like an oxymoron, a University of Iowa ... skull from a "pygmy-sized" giant panda -- the earliest-known ancestor ... some two million years ago. , The ancestor of today's ... Ciochon, UI professor of anthropology. Ciochon (pronounced schuh-HON) is a ...
... the link between the way an animal moves and the dimensions ... semicircular canals of the inner ear on each side of the ... on 26 June in the print edition of the Proceedings of ... edition during the week of 18 to 22 June. , ...
... cells that is altered by genetic mutations recently identified in ... mutations affect cellular function and could provide a target for ... a team of Emory University scientists will be published June ... journal. , Parkinson disease is a degenerative disorder ...
Cached Biology News:UI anthropologist, colleagues discover remains of earliest giant panda 2Reconstructing the biology of extinct species: A new approach 2Researchers identify protein pathway involved in Parkinson disease development 2
Anti-TWIK-1 Immunogen: Purified peptide from amino acids 53-69 of human TWIK-1 (Accession number O00180)....
Monoclonal 8C2.1 is specific for Bunyavirus G1 as tested by neutralization, immunoprecipitation and immunobinding assays....
BI-1 Polyclonal Antibody Storage Temperature: -20C Shipping: gel pack Shelf-Life: 12 months...
...
Biology Products: