Navigation Links
Immune Deficiency Foundation Urges FDA To Exempt Immunoglobulin From Biosimilars Pathway
Date:5/17/2012

BALTIMORE, May 16, 2012 /PRNewswire/ -- In an effort to voice concern on biosimilars pathways for patients with primary immunodeficiency diseases (PIDD), the Immune Deficiency Foundation (IDF) offered oral testimony at last week's U.S. Food and Drug Administration (FDA) public hearing on draft guidance of biosimilars products. IDF urged the FDA to exempt immunoglobulin (Ig) therapies from the biosimilars pathways in order to protect the safety of patients with PIDD.

PIDD occurs in people born with an immune system that is either absent or hindered in its ability to function, causing an array of illnesses. Many of these patients require Ig therapy, a biologic medicine, for long-term management. Ig therapies are derived from human blood product, or plasma, and can differ in terms of processing and end composition.

"The FDA should restrict Ig therapies from the biosimilars pathways until the science advances significantly," said Marcia Boyle, president and founder, IDF. "Patients with primary immunodeficiency diseases depend on frequent antibody replacements with Ig therapy in order to fight infections."

The FDA recognizes each Ig brand as unique with no generic equivalent— Ig products are not clinically interchangeable. Current science cannot demonstrate that two products will provide the exact same clinical results for a large number of patients or that switching patients from one product to another will pose no additional risks.

Boyle's testimony urged the FDA to follow the example set by the European Medicines Agency and exempt Ig therapy from the biosimilars pathway, or to at the least require that biosimilars products undergo clinical trials to determine whether a proposed interchangeable therapy will offer patients the same clinical outcome. Additionally, Boyle requested that the FDA prohibit automatic substitution of a biosimilars with an original biologic.

"We believe the FDA's foremost responsibility is to ensure that biosimilars are manufactured and prescribed safely," said Boyle. "All medicines must be thoroughly tested and meet the highest safety standards set by the FDA."

About the Immune Deficiency Foundation

The Immune Deficiency Foundation is the national patient organization dedicated to improving the diagnosis, treatment and quality of life of persons with primary immunodeficiency diseases through advocacy, education, and research.  www.primaryimmune.org.


'/>"/>
SOURCE Immune Deficiency Foundation
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. AutoImmune Inc. Reports 2008 Second Quarter Financial Results
2. Peptimmune Presentation at Upcoming World Congress on Treatment and Research in Multiple Sclerosis
3. EUPROBIO 2008 Presentation to Highlight Latest Immune Research
4. MedImmune Presents Data at AAP National Conference & Exhibition Demonstrating Burden of RSV Disease
5. MedImmune Expands R&D Capacity with New Research Facility in Cambridge, U.K.
6. MedImmune Licenses Reverse Genetics Technology to Hungarys Omninvest for Use in Influenza Vaccine Development and Production
7. MedImmune Presents Data Highlighting its Progressive Inflammatory Disease Portfolio at the 72nd Annual Meeting of the American College of Rheumatology
8. Peptimmune Presentations at Upcoming Events
9. Protein-printing technique gives snapshots of immune system defense
10. Visualizing asthma-causing immune cells at work
11. AutoImmune Inc. Reports 2008 Third Quarter Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/29/2017)... ... ... On the heels of the globally recognized Rare Disease Day , ... it will manage travel services for its 500th clinical trial this month. The company, ... Europe to offer travel management services specifically for clinical trials and their sponsors, and ...
(Date:3/29/2017)... 29, 2017 Research and Markets has announced ... Trends - Industry Forecast to 2025" report to their offering. ... The Global ... around 7.8% over the next decade to reach approximately $825.4 million ... estimates and forecasts for all the given segments on global as ...
(Date:3/29/2017)... , Mar. 29, 2017 Research and ... Emerging Technologies and Global Markets" report to their offering. ... ... generation DNA sequencing, biochips, RNA interference, synthetic biology tools and ... and biologicals. These technologies and products are analyzed ...
(Date:3/28/2017)... ... March 28, 2017 , ... Mass spectrometry is becoming ... of this technology is driven by its potential to perform challenging analyses in complex ... some challenges that must be addressed for it to be routinely used for medical ...
Breaking Biology Technology:
(Date:3/27/2017)... March 27, 2017  Catholic Health Services (CHS) ... Systems Society (HIMSS) Analytics for achieving Stage 6 ... sm . In addition, CHS previously earned a ... using an electronic medical record (EMR). ... level of EMR usage in an outpatient setting.  ...
(Date:3/23/2017)... The report "Gesture Recognition and Touchless Sensing Market by Technology (Touch-based ... to 2022", published by MarketsandMarkets, the market is expected to be worth USD ... 2022. Continue Reading ... ... ...
(Date:3/22/2017)... YORK , March 21, 2017 ... Marketing Cloud used by retailers such as 1-800-Flowers ... its platform — Product Recommendations and Replenishment. Using Optimove,s ... give more personalized product and replenishment recommendations to ... but also on predictions of customer intent drawn ...
Breaking Biology News(10 mins):