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:7/30/2014)... W. R. Grace & Co. ... REVELERIS® Prep purification system , a dual-mode ... other researchers to perform both flash and preparative ... With the REVELERIS® Prep purification system, researchers can ... with a simple touch of the screen, giving ...
(Date:7/30/2014)... July 30, 2014 While administrative ... health services research for a relatively long period ... interest regarding the use of these ‘big data’ ... , By combining today’s powerful computer technology with ... era, ‘big data’ holds significant promise for identifying ...
(Date:7/30/2014)... STONY BROOK, NY (PRWEB) July 30, 2014 ... (OTCQB: APDN), (Twitter: @APDN), a biotechnology firm that provides ... Dr. Michael E. Hogan, Ph.D. Vice President of Life ... in mid-September. , Dr. Hogan will lead ... to form business relationships with biotech and healthcare customers, ...
(Date:7/30/2014)... 30, 2014  Dyadic International, Inc. ("Dyadic") (OTCQX: ... and proprietary technologies are used to discover, develop, ... the bioenergy, bio-based chemical, biopharmaceutical and industrial enzyme ... Dubinski as Vice President and Chief Financial Officer. ... and information technology operations for Dyadic and will ...
Breaking Biology Technology:Grace Launches New REVELERIS® Prep Purification System 2Leveraging ‘Big Data’ - Methodological Considerations in Health Services Research, New Webinar Hosted by Xtalks 2Dr. Michael E. Hogan, Ph.D., Joins Applied DNA Sciences as Vice President, Life Sciences 2Dr. Michael E. Hogan, Ph.D., Joins Applied DNA Sciences as Vice President, Life Sciences 3Thomas Dubinski joins Dyadic as Chief Financial Officer 2Thomas Dubinski joins Dyadic as Chief Financial Officer 3Thomas Dubinski joins Dyadic as Chief Financial Officer 4
... 1, 2011 Life Technologies Corporation (Nasdaq: ... webcasting management presentations to investors as part of the ... which is being held at the company,s headquarters in ...  Mark Stevenson, Life Technologies, President and Chief Operating Officer, ...
... NEW YORK, March 1, 2011 NeoStem, Inc. (NYSE Amex: ... in the U.S. and China, announced today that Dr. Robert ... Therapy ("PCT"), a wholly-owned subsidiary of NeoStem, Inc., has been ... 6th Annual New York Stem Cell Summit. The Summit will ...
... BioNeutral Group, Inc. (OTC Bulletin Board: ... announced that its wholly-owned subsidiary, BioNeutral Services, Inc., has ... (KEDFA) to receive up to $280,000 in development incentives ... February 24 meeting, six companies, including BioNeutral Services, Inc., ...
Cached Biology Technology:Life Technologies to Webcast Investor Presentation as Part of the UBS West Coast Life Sciences & Diagnostics Bus Trip 2Progenitor Cell Therapy to Present at 6th Annual New York Stem Cell Summit on Tuesday, March 1 2Progenitor Cell Therapy to Present at 6th Annual New York Stem Cell Summit on Tuesday, March 1 3Progenitor Cell Therapy to Present at 6th Annual New York Stem Cell Summit on Tuesday, March 1 4BioNeutral Group to Receive Economic Development Incentives 2BioNeutral Group to Receive Economic Development Incentives 3
(Date:7/31/2014)... marine noise can affect animal movement and communication, with ... and Exeter and the cole Pratique des Hautes tudes ... stops embryonic development and increases larval mortality in sea ... Stylocheilus striatus used in this study) usually hatch ... on toxic alga but this study, conducted in a ...
(Date:7/30/2014)... at New York University is paving the way ... in civilians and military troops exposed to poisonous ... , An article in the current issue of ... in detoxifying organophosphates, which are compounds commonly used ... was developed by NYU School of Engineering Associate ...
(Date:7/30/2014)... in Lewis Carroll,s Through the Looking Glass, collaborators ... of Singapore improved a 35-year-old ecology model to ... millions of years. , The new model, called ... "Red Queen Effect," an evolutionary hypothesis introduced by ... that organisms must constantly increase their fitness (or ...
Breaking Biology News(10 mins):Boat noise impacts development and survival of sea hares 2Engineering a protein to prevent brain damage from toxic agents 2Classic Lewis Carroll character inspires new ecological model 2Classic Lewis Carroll character inspires new ecological model 3
... likely impact of ocean acidification on shellfish and other marine ... is published this week (date) in the journal Global ... because some of the increased carbon dioxide humans are adding ... water to produce an acid. The results suggest that ...
... by the National Science Foundation (NSF) found state agency ... fiscal year 2009, a 7 percent increase over the ... details nationwide and state-by-state totals of R&D activities performed ... first time survey data are available by individual state ...
... release is available in German . Tomato ... with a genetic defect that made the fruits mature very slowly, ... were delighted as it gave them more time to transport the ... it would be sold. At the stores, the tomatoes could then ...
Cached Biology News:New study helps predict impact of ocean acidification on shellfish 2New study helps predict impact of ocean acidification on shellfish 3Ethylene of no effect -- why peppers do not mature after picking 2
...
... suitable for sizing linear double-stranded DNA from 9 ... 13 bands consist of 8.3- to 48.5-kb fragments ... (cIind1ts857 Sam7). Ethidium bromide staining causes the four ... bp 12220 bp and 19399 bp) to show ...
... ZMD.358. Immunogen: Synthetic peptide ... of human mouse and rat ... human and mouse LRP5 proteins. ... controls: mouse LRP5-pSEC-tag-transfected 293T cells ...
MarrowMAX Bone Marrow Medium...
Biology Products: