Navigation Links
Amgen to Provide Testimony at FDA Hearing on Biosimilars
Date:11/1/2010

THOUSAND OAKS, Calif., Nov. 1, 2010 /PRNewswire/ -- Amgen (Nasdaq: AMGN) Senior Vice President of Research and Development Joe Miletich, M.D., Ph.D., will urge members of a U.S. Food and Drug Administration (FDA) panel charged with implementing a pathway for biosimilars to establish approval standards that ensure patient safety and follow a science-based approach.

"Put patients first and sound policy will follow," Dr. Miletich said.  "Amgen believes biosimilars have a meaningful role to play in the health care system.  However, biosimilars—unlike generic drugs—are not identical to the innovative biological products."  Getting the biosimilar pathway 'right' could benefit the future of biopharmaceuticals, whereas "imprudent policy" could simultaneously put patients unacceptably at risk, undermine the policy goals and set back the promise of new biologic treatments for patients.Noting the complexities of biological products and the likely differences in products created from different living cells, Dr. Miletich will outline three key recommendations that the FDA should consider as it moves forward:

  1. Use well-designed clinical trials to establish biosimilarity;
  2. Ensure the product manufacturer and lot number is known for all administered biological; and
  3. Set scientific and practical criteria for interchangeability.

"The question before the agency is how we can minimize patient risk and uncertainty associated with the approval of biosimilars," Dr. Miletich said.  "The challenge with biosimilars is knowing which structural variations matter clinically and which do not.  Many differences probably do not matter, while some differences are important.  Other differences remain open questions.  Clinical evaluations and experience are necessary to address these questions."'/>"/>

SOURCE Amgen
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. Amgen Announces Webcast of 2008 Third Quarter Financial Results
2. Amgens Third Quarter 2008 Adjusted Earnings Per Share Increased 14 Percent to $1.23
3. Call for Applications: The Amgen Award for Science Teaching Excellence
4. Amgen to Webcast 2008 Business Review Meeting on November 7 From Millennium Hotel in New York
5. Amgen Positioned to Deliver Attractive Growth Over Next Five Years
6. Amgen Foundation Announces $2.5 Million Expansion of Amgen Scholars Program to Europe
7. Amgen to Present at the 27th Annual JP Morgan Healthcare Conference
8. Amgen Announces Webcast of 2008 Fourth Quarter and Full Year Financial Results
9. Amgens Breakaway from Cancer Initiative Expands to Help Cancer Patients Access Broad Spectrum of Cancer Resources and Services
10. Amgens Fourth Quarter 2008 Adjusted Earnings Per Share Increased 6 Percent to $1.06; Full Year 2008 Adjusted Earnings Per Share Increased 6 Percent to $4.55
11. FDA Accepts Amgens Submission and Files Biologics License Application for Denosumab
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/29/2014)... Boston, MA (PRWEB) August 29, 2014 Due ... (FRC) last week, the Adult Stem Cell Technology Center, ... donations to support stem cell therapy research that might benefit ... adult stem cells for new stem cell technologies and therapeutic ... ALS Ice Bucket Challenge donors who wish not ...
(Date:8/28/2014)... August 28, 2014 SPIE Fellow Glenn ... and Optical Science and Director of the Center for ... Carolina at Charlotte, and co-founder and Chairman of the ... as the 2015 Vice President of SPIE, the international ... Philip Stahl announced recent election results at the Annual ...
(Date:8/28/2014)... 2014 “This kit has an improved extraction ... 0 to 150 ppb,” said Mark Tess, PhD, Mycotoxin Product ... to plant owners and USDA-GIPSA inspection agencies that have a ... can take place in a matter of minutes with nothing ... test the feed and grain before accepting it, but they ...
(Date:8/28/2014)... NEW YORK , Aug. ... announces that a new market ... its catalogue: Whole ... (Systems, Kits (Library Preparation, Target ... Technology (Sequencing by Synthesis), by ...
Breaking Biology Technology:The Adult Stem Cell Technology Center, LLC Declines ALS Ice Bucket Challenge Donors Wishing to Support Ethical Research for New Stem Cell Therapies 2The Adult Stem Cell Technology Center, LLC Declines ALS Ice Bucket Challenge Donors Wishing to Support Ethical Research for New Stem Cell Therapies 3Glenn Boreman, UNC Professor and Plasmonics Co-Founder, Elected to SPIE Presidential Chain 2Whole Exome Sequencing Market by Product (Systems, Kits (Library Preparation, Target Enrichment), by Services (Sequencing), by Technology (Sequencing by Synthesis), by Application (Cancer, Monogenic disorders) - Global Forecast to 2018 2Whole Exome Sequencing Market by Product (Systems, Kits (Library Preparation, Target Enrichment), by Services (Sequencing), by Technology (Sequencing by Synthesis), by Application (Cancer, Monogenic disorders) - Global Forecast to 2018 3Whole Exome Sequencing Market by Product (Systems, Kits (Library Preparation, Target Enrichment), by Services (Sequencing), by Technology (Sequencing by Synthesis), by Application (Cancer, Monogenic disorders) - Global Forecast to 2018 4Whole Exome Sequencing Market by Product (Systems, Kits (Library Preparation, Target Enrichment), by Services (Sequencing), by Technology (Sequencing by Synthesis), by Application (Cancer, Monogenic disorders) - Global Forecast to 2018 5Whole Exome Sequencing Market by Product (Systems, Kits (Library Preparation, Target Enrichment), by Services (Sequencing), by Technology (Sequencing by Synthesis), by Application (Cancer, Monogenic disorders) - Global Forecast to 2018 6Whole Exome Sequencing Market by Product (Systems, Kits (Library Preparation, Target Enrichment), by Services (Sequencing), by Technology (Sequencing by Synthesis), by Application (Cancer, Monogenic disorders) - Global Forecast to 2018 7Whole Exome Sequencing Market by Product (Systems, Kits (Library Preparation, Target Enrichment), by Services (Sequencing), by Technology (Sequencing by Synthesis), by Application (Cancer, Monogenic disorders) - Global Forecast to 2018 8Whole Exome Sequencing Market by Product (Systems, Kits (Library Preparation, Target Enrichment), by Services (Sequencing), by Technology (Sequencing by Synthesis), by Application (Cancer, Monogenic disorders) - Global Forecast to 2018 9Whole Exome Sequencing Market by Product (Systems, Kits (Library Preparation, Target Enrichment), by Services (Sequencing), by Technology (Sequencing by Synthesis), by Application (Cancer, Monogenic disorders) - Global Forecast to 2018 10Whole Exome Sequencing Market by Product (Systems, Kits (Library Preparation, Target Enrichment), by Services (Sequencing), by Technology (Sequencing by Synthesis), by Application (Cancer, Monogenic disorders) - Global Forecast to 2018 11Whole Exome Sequencing Market by Product (Systems, Kits (Library Preparation, Target Enrichment), by Services (Sequencing), by Technology (Sequencing by Synthesis), by Application (Cancer, Monogenic disorders) - Global Forecast to 2018 12Whole Exome Sequencing Market by Product (Systems, Kits (Library Preparation, Target Enrichment), by Services (Sequencing), by Technology (Sequencing by Synthesis), by Application (Cancer, Monogenic disorders) - Global Forecast to 2018 13
... EVENT ... DATE, Publication of the Annual Report for 2007 ... Wednesday, April 23, 2008, Publication ... 2008, Publication of the Interim Report for the Wednesday, August 27, 2008 ...
... as the "holy grail" of nanoscience, researchers at the ... the first time used DNA to guide the creation ... dimensions measured in billionths of a meter). The ability ... functional materials that take advantage of the unique properties ...
... Search ... Underway, ... GNLB ) announced today that James A. D. Smith,has resigned as ... 2008. Irene A. Chow, Ph.D., Executive,Chairman of Genelabs, Board of Directors, ...
Cached Biology Technology:Genmab's Financial Calendar for 2008 2DNA technique yields 3-D crystalline organization of nanoparticles 2DNA technique yields 3-D crystalline organization of nanoparticles 3Genelabs Technologies, Inc. Announces Resignation of President and CEO 2
(Date:8/28/2014)... A unique method for delivering compounds that ... HIV and AIDS may be possible, thanks ... Agricultural Sciences., A semi-soft vaginal suppository made ... loaded with the antiviral drug Tenofovir provides ... against the spread of sexually transmitted infections ...
(Date:8/28/2014)... Energy production systems are good examples of complex ... like a networkincluding water for cooling, transport to ... management. Every step in the network chain is ... all mutually dependent. A team of UK-based scientists ... previously explored. The findings have been published in ...
(Date:8/28/2014)... August 28, 2014 Dyslexia, the most commonly ... a neurological reading disability that occurs when the ... don,t function normally. , The use of non-invasive ... activity is disrupted in dyslexia. However, most prior ... of brain regions, leaving a gap in our ...
Breaking Biology News(10 mins):Sensory-tested drug-delivery vehicle could limit spread of HIV, AIDS 2Sensory-tested drug-delivery vehicle could limit spread of HIV, AIDS 3Inter-dependent networks stress test 2Dyslexic readers have disrupted network connections in the brain 2
... all" when it comes to weight loss through exercise, says ... Neil King, from QUT,s Institute of Health and Biomedical Innovation, ... with the University of Leeds in the UK, which has ... of Obesity. "When it comes to losing weight, a ...
... Des Moines, Iowa November 1, 2007 Officials ... research facility in Des Moines, announced today the organization ... conservation efforts. Dr. Benjamin Beck, director of conservation ... 46 percent increase over 2006 levels. In the ...
... the table. Now, scientists at North Carolina State University ... are more sensitive to alcohol than others. And the results ... After genetically modifying fruit flies to be either extremely sensitive ... the NC State scientists found that a number of fruit ...
Cached Biology News:Weight loss -- not one size fits all 2Great Ape Trust awards $127,000 for international conservation efforts 2Great Ape Trust awards $127,000 for international conservation efforts 3Great Ape Trust awards $127,000 for international conservation efforts 4Lush or lightweight? 2
Anti-Human IFN-Gamma Receptor Chain 2 (beta chain) [CD119], Rabbit serum, NON-neutralizing polyclonal antibody...
AANAT [Arylalkylamine N-acetyltransferase; EC 2.3.1.87]...
Rac1/2/3 (L129) Antibody Shipping Temperature: HOT Storage Temperature: -20C...
Sheep polyclonal to EBNA 3B ( Abpromise for all tested applications). Antigen: Full length protein....
Biology Products: