Navigation Links
Alliance for Safe Biologic Medicines Chairman Urges FDA to Ensure that Patient Safety is the Cornerstone of Biosimilar Pathway
Date:5/11/2012

WASHINGTON, May 11, 2012 /PRNewswire-USNewswire/ -- Dr. Richard Dolinar, chairman of the Alliance for Safe Biologic Medicines (Alliance) outlined five areas of concern that the U.S. Food and Drug Administration (FDA) should resolve before they allow biosimilar medications on the U.S. drug market in prepared testimony for the FDA's May 11th public hearing.  The event addressed the FDA's recent draft guidelines for the development of biosimilar products.

"We applaud the FDA's efforts to bring biosimilars to the U.S. market, but would urge a deliberate approach that is becoming of FDA's critical role of ensuring the safety and efficacy of the nation's drug supply," Dr. Dolinar said.  "The members of the Alliance support the goal of the health care law to bring broader access to biologic medicines to patients across the country and we want to ensure that biosimilar medicines are as safe as the innovator drugs they seek to replicate."

During his testimony, Dr. Dolinar, a practicing endocrinologist, outlined (1) the need for robust clinical testing; (2) the establishment of steps to monitor the global supply chain and manufacturing process; (3) the creation of track, trace and naming provisions; (4) the development of clear packaging, labeling and prescribing information; and (5) very close and deliberate scrutiny of a biosimilar before it is deemed interchangeable.

"Biologics are complex, large molecule drugs that are grown inside living cells using unique and proprietary processes," Dr. Dolinar said during his testimony.  "For this reason, no two biologics made from different cell lines or using different processes can be identical based on today's science.  Biologics are also highly sensitive to the manufacturing process. In fact, altering a single manufacturing parameter can change a compound's identity and/or the precise effect it has on the human body."

Dr. Dolinar's remarks to Dr. Rachel Sherman and other FDA panel members summarized the comments the Alliance submitted last month in response to the FDA's draft guidance on the approval of biosimilar medicines.  The Alliance's written submission outlined clear, concrete and achievable ways to manage risk and prioritize patient safety. 

To speak to Dr. Dolinar or another member of the Alliance for Safe Biologic Medicines, please email media@safebiologics.org

About the Alliance for Safe Biologic Medicines

The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, innovative medical biotechnology companies, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion. We serve as an authoritative resource center of information for the public, medical communities, the FDA and other state and federal policymakers during the implementation of the biosimilars pathway and beyond.  Visit us at www.safebiologics.org.


'/>"/>
SOURCE Alliance for Safe Biologic Medicines
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Donor Alliance Honors Families at the 2012 Donor Family Tribute
2. Genomic Health and OncoMed Announce Strategic Alliance for Biomarker Research and Discovery Using Next Generation Sequencing
3. Donor Alliance Honored By Colorado Legislature In Observation Of National Donate Life Month
4. Music Legend And Health Advocate Bret Michaels To Address Diversity Alliance For Science 2012 National Conference And EXPO
5. Narayana Hrudayalaya Hospitals Teams With Ascension Health Alliance to Build Health City at Grand Cayman
6. Psyche Systems Corporation Signs Strategic Alliance with Siemens Healthcare to Provide Anatomic Pathology Solutions
7. framergyTM to partner with the Space Alliance Technology Outreach Program
8. Campbell Alliance Launches Market Research and Analytics Group, Appoints Michael Turner as General Manager of Encuity Research
9. Systems Alliance Launches Redesigned Website for The Living Legacy Foundation of Maryland
10. SiREM and Tersus Environmental Form Strategic Marketing Alliance
11. PAREXEL and ASAN Medical Center Establish Alliance to Accelerate Korea-based Drug Development and Commercialization Programs
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... , June 23, 2016   EpiBiome , ... secured $1 million in debt financing from Silicon Valley ... up automation and to advance its drug development efforts, ... new facility. "SVB has been an incredible ... the services a traditional bank would provide," said Dr. ...
(Date:6/23/2016)... ... June 23, 2016 , ... In a new case report published today ... a patient who developed lymphedema after being treated for breast cancer benefitted from an ... paradigm for dealing with this debilitating, frequent side effect of cancer treatment. ...
(Date:6/23/2016)... , June 23, 2016 ... Hematology Review, 2016;12(1):22-8 http://doi.org/10.17925/OHR.2016.12.01.22 ... , the peer-reviewed journal from touchONCOLOGY, Andrew ... escalating cost of cancer care is placing an ... result of expensive biologic therapies. With the patents ...
(Date:6/23/2016)... (PRWEB) , ... June 23, 2016 , ... ... on quality, regulatory and technical consulting, provides a free webinar on ... on July 13, 2016 at 12pm CT at no charge. , Incomplete investigations ...
Breaking Biology Technology:
(Date:5/16/2016)... NEW YORK , May 16, 2016   ... authentication solutions, today announced the opening of an IoT ... to strengthen and expand the development of embedded ... provides an unprecedented level of convenience and security with ... to authenticate one,s identity aside from DNA. EyeLock,s platform ...
(Date:4/28/2016)... First quarter 2016:   , ... the first quarter of 2015 The gross margin was ... 18.8) and the operating margin was 40% (-13) Earnings ... flow from operations was SEK 249.9 M (21.2) , ... SEK 7,000-8,500 M. The operating margin for 2016 is ...
(Date:4/15/2016)... , April 15, 2016 ... the,  "Global Gait Biometrics Market 2016-2020,"  report to ... http://photos.prnewswire.com/prnh/20160330/349511LOGO ) , ,The global gait biometrics ... of 13.98% during the period 2016-2020. ... angles, which can be used to compute factors ...
Breaking Biology News(10 mins):