Navigation Links
Alliance for Safe Biologic Medicines Chairman Urges FDA to Ensure that Patient Safety is the Cornerstone of Biosimilar Pathway

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Sherman and other FDA panel members summarized the comments the Alliance submitted last month in response to the FDA's draft guidance on the approval of biosimilar medicines.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

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

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:
(Date:11/24/2015)... SAN DIEGO , Nov. 24, 2015 Halozyme Therapeutics, ... Jaffray Healthcare Conference in New York on ... Dr. Helen Torley , president and CEO, will provide a ... New York at 1:00 p.m. ET/10:00 a.m. ... communication and investor relations, will provide a corporate overview. --> ...
(Date:11/24/2015)... , Nov. 24, 2015 /PRNewswire/ - Aeterna Zentaris Inc. ... IIROC on behalf of the Toronto Stock Exchange, confirms ... there are no corporate developments that would cause the ... --> --> About Aeterna Zentaris ... . --> Aeterna Zentaris is a specialty ...
(Date:11/24/2015)... ... 2015 , ... The Academy of Model Aeronautics (AMA), led by its Executive ... Multirotor Grand Prix, to represent the First–Person View (FPV) racing community. , FPV racing ... this type of racing and several new model aviation pilots have joined the community ...
(Date:11/24/2015)... Nov. 24, 2015 /PRNewswire/ - Aeterna Zentaris Inc. ... that the remaining 11,000 post-share consolidation (or 1,100,000 ... (the "Series B Warrants") subject to the previously ... November 23, 2015, which will result in the ... effect to the issuance of such shares, there ...
Breaking Biology Technology:
(Date:11/17/2015)... , Nov. 17, 2015 Pressure BioSciences, ... in the development and sale of broadly enabling, pressure ... life sciences industry, today announced it has received gross ... $5 million Private Placement (the "Offering"), increasing the total ...  One or more additional closings are expected in the ...
(Date:11/11/2015)... 2015   MedNet Solutions , an innovative SaaS-based eClinical ... is pleased to announce that it will be a Sponsor ... event, to be held November 17-19 in Hamburg ... demonstrations of iMedNet , MedNet,s easy-to-use, proven ... has been able to deliver time and cost savings ...
(Date:11/4/2015)... --> --> ... Transparency Market Research "Home Security Solutions Market - Global Industry ... 2022", the global home security solutions market is expected to reach ... market is estimated to expand at a CAGR of ... Rising security needs among customers at homes, the emergence ...
Breaking Biology News(10 mins):