Navigation Links
Immune Deficiency Foundation Urges FDA To Exempt Immunoglobulin From Biosimilars Pathway

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Foundation (IDF) offered oral testimony at last week's U.S. Food and Drug Administration (FDA) public hearing on draft guidance of biosimilars products.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.

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:
(Date:11/24/2015)... Nov. 24, 2015 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: ... on behalf of the Toronto Stock Exchange, confirms that ... are no corporate developments that would cause the recent ... --> --> About Aeterna Zentaris Inc. ... --> Aeterna Zentaris is a specialty biopharmaceutical ...
(Date:11/24/2015)... ... 24, 2015 , ... This fall, global software solutions leader SAP and AdVenture ... develop and pitch their BIG ideas to improve health and wellness in their schools. ... to win the title of SAP's Teen Innovator, an all-expenses paid trip to Super ...
(Date:11/24/2015)... November 24, 2015 --> ... research report released by Transparency Market Research, the global ... a CAGR of 17.5% during the period between 2014 ... - Global Industry Analysis, Size, Volume, Share, Growth, Trends ... prenatal testing market to reach a valuation of US$2.38 ...
(Date:11/24/2015)... 2015  Twist Bioscience, a company focused on ... Twist Bioscience chief executive officer, will present at ... 1, 2015 at 3:10 p.m. Eastern Time at The Lotte ... --> --> About ... is on Twitter. Sign up to follow our ...
Breaking Biology Technology:
(Date:10/26/2015)... LAS VEGAS , Oct. 26, 2015 /PRNewswire/ ... innovator in modern authentication and a founding member of ... of its latest version of the Nok Nok™ S3 ... use standards-based authentication that supports existing and emerging methods ... is ideal for organizations deploying customer-facing applications that require ...
(Date:10/23/2015)... Oct. 23, 2015 Research and Markets ( ... "Global Voice Recognition Biometrics Market 2015-2019" report to ... --> The global voice recognition biometrics market to ... --> --> The ... prepared based on an in-depth market analysis with inputs ...
(Date:10/22/2015)... (NASDAQ: AWRE ), a leading supplier of biometrics software and ... 30, 2015.  --> --> ... decrease of 33% compared to $6.0 million in the same quarter ... $2.2 million, or $0.10 per diluted share, which compared to $2.6 ... year ago.  --> --> ...
Breaking Biology News(10 mins):