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:9/2/2014)... September 02, 2014 The inventors of ... for chronic tinnitus are seeking support for development costs ... Indiegogo platform ( http://igg.me/at/tinaway ), was launched on September ... therapeutic ‘mHealth’ app and is based on ten years ... team of biomedical and software engineers, Dr. Ian Dixon ...
(Date:8/31/2014)... PARSIPPANY, N.J. , Aug. 31, 2014 ... New Drug Discovery program in Anti-Infective research when two ... the coveted Qualified Infectious Disease Product (QIDP) status from ... granted to drugs which act against pathogens which have ... and are identified by Centre for Disease Control (a ...
(Date:8/30/2014)... (PRWEB) August 31, 2014 The ... a professional and in-depth study on the current ... Global and China. , The report provides a ... and industry chain structure. Global market analysis and ... focus on history, developments, trends and competitive landscape ...
(Date:8/29/2014)... According to a new market report published by ... was valued at USD 3,754.6 million in 2012 and is ... a CAGR of 5.9% from 2013 to 2019. , Nearly ... afflicted by bone and joint disorders, and this number is ... and will continue to increase the demand for orthobiologics. Other ...
Breaking Biology Technology:tinAway Pty. Ltd. launch a crowdfunding campaign to fund a clinical trial of tinAway, a new potential cure for chronic tinnitus 2tinAway Pty. Ltd. launch a crowdfunding campaign to fund a clinical trial of tinAway, a new potential cure for chronic tinnitus 3tinAway Pty. Ltd. launch a crowdfunding campaign to fund a clinical trial of tinAway, a new potential cure for chronic tinnitus 4tinAway Pty. Ltd. launch a crowdfunding campaign to fund a clinical trial of tinAway, a new potential cure for chronic tinnitus 5U.S. FDA Grants QIDP Status for Wockhardt Anti-Infective Drug Discovery Program 2U.S. FDA Grants QIDP Status for Wockhardt Anti-Infective Drug Discovery Program 3Electrical Insulating Varnish Market World, China Regional Analysis & 2020 Forecasts Available at DeepResearchReports.com 2Electrical Insulating Varnish Market World, China Regional Analysis & 2020 Forecasts Available at DeepResearchReports.com 3Global Orthobiologics Market to Reach $5,519.9 Million by 2019: Transparency Market Research 2Global Orthobiologics Market to Reach $5,519.9 Million by 2019: Transparency Market Research 3
... Inc. (NYSE Amex: CUR ) announced it ... develop its human neural stem cell technology for the ... "Research to Treat Cancerous Brain Tumors with Neural Stem ... Investigator John Zhang, MD, PhD, Professor of Neurosurgery, Loma ...
... that attacks the small intestines of humans and animals ... can fight disease and aid in military operations. ... engineering, at the University of Tennessee, Knoxville, and his ... attachment of the microorganism Giardia. Giardia causes one of ...
... Informex , the leading meeting place for buyers ... introduction of a new conference, ,Business Strategies for ... to be hosted October 5-6th, 2011 in Boston, ... topics regarding the future of pharma, sourcing strategies ...
Cached Biology Technology:Neuralstem Awarded Department of Defense Contract for Brain Cancer Research 2Neuralstem Awarded Department of Defense Contract for Brain Cancer Research 3UT professor's pathogen research inspires robotics design for medicine and military 2New Conference Offers Solutions for Success in the Growing Biologics Market 2New Conference Offers Solutions for Success in the Growing Biologics Market 3
(Date:9/2/2014)... suggests that professional baseball pitchers with poor core stability are ... single season because of injury than are pitchers who have ... , In the study, 347 pitchers were assessed for lumbopelvic ... pelvis as they raised a leg to step up were ... 30 days cumulative, not consecutive during the season ...
(Date:9/2/2014)... If you think losing weight is enough to prevent Type ... report in September 2014 issue of The FASEB ... overweight to develop Type 2 diabetes. This study compared genetically ... a fast-food meal, the circulating metabolites, including those related to ... same levels. These findings suggest that the onset of ...
(Date:9/2/2014)... (September 2, 2014) In the battle between our ... unknown ally in bacteria-killing viruses known as phages. In ... Hospital, Partners In Health, Haiti,s National Public Health Laboratory, ... to give up their virulence in order to survive. ... found that cholera,s mutational escape from phage predation ...
Breaking Biology News(10 mins):In pro baseball pitchers, weak core linked to more missed days 2In pro baseball pitchers, weak core linked to more missed days 3What you eat and not just the number of calories, is a significant factor in diabetes risk 2War between bacteria and phages benefits humans 2War between bacteria and phages benefits humans 3
... Long touted as an energy-saving alternative for home ... to be even more efficient, as well as dimmable, ... by householders as a longer-lasting, energy efficient alternative to ... the power and last 1,000 times longer than incandescent ...
... and her colleagues have identified a specific DNA change ... in some people. It provides a potential mechanism that ... consistent with the growing trend of personalized medicine. ... issue of the American Journal of Psychiatry ...
... used as live bait for freshwater fishing. With ... channel catfish and other freshwater fishes. They may ... in bait shops in Arizona, Colorado and New Mexico ... a chytrid fungus called Batrachochytrium dendrobatidis (Bd). "These ...
Cached Biology News:Queen's researchers shine light on compact fluorescent bulb problems 2Altered gene can increase risk of schizophrenia 2Altered gene can increase risk of schizophrenia 3Spring fishing season arrives... and with it, amphibian diseases 2Spring fishing season arrives... and with it, amphibian diseases 3
...
Human/Mouse/Rat p38 alpha Affinity Purified PAb...
sterile filtered, off the clot, all male donors, Total Protein: 4.5 to 8.5 g/dl...
Human alpha-1-antitrypsin. No cross-reactivity with alpha-1-acid glycoprotein, serum albumin or other serum proteins....
Biology Products: