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

e scope of harm from unexpected adverse events associated with use of any biological product.  These measures should include development and implementation of a pharmacovigilance system that provides accurate and comprehensive association and reporting of adverse events with the implicated product, as well as specific labeling to differentiate products that are biosimilar from those that are interchangeable to enable physicians to make informed treatment decisions.

In his concluding comments, Dr. Miletich urged the FDA to outline approval standards through a transparent and public process.  "Not all classes of biological products have the same level of complexity or risk, thus class-specific approval standards must be developed," Dr. Miletich stated.  "Case-by-case approaches generate uncertainty leading to delays and increased cost.  Class-by-class standards are consistent with good review practices.  A public process for approval standards creates confidence among patients and physicians."

On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act which contained a provision authorizing the FDA to create an abbreviated approval pathway for biological products shown to be biosimilar to with an already FDA-approved biological medicine.  Several countries around the globe have already implemented approval pathways for biosimilars.  The European Union and Japan are among those that have successfully devised a set of science-based criteria to permit biosimilars in their jurisdictions.  With the FDA's hearing on November 2-3, the United States is beginning the implementation process.

Dr. Miletich’s testimony was submitted in response to FDA’s

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:5/5/2015)... , May 5, 2015 CytomX, a ... cancer, today announced that Sean McCarthy , D. ... Suisse Antibody Day in New York ... Dr. McCarthy will present an overview of CytomX,s Probody ... drug conjugate programs. About CytomX Therapeutics ...
(Date:5/5/2015)... 2015   Tocagen Inc. , a clinical-stage ... Parkinson , M.D., a venture partner at New ... board of directors of Tocagen. Dr. Parkinson has ... clinical development, including leading clinical activities at Amgen ... the cancer therapeutics Gleevec®, Femara®, Zometa®, Kepivance® and ...
(Date:5/5/2015)... College Station, TX (PRWEB) May 05, 2015 ... Pfizer were announced last week as recipients of ... Technology Innovation in recognition of their Portable, Continuous, ... system that integrates a small footprint, continuous processing ... GMP modules) to process API powders and inactive ...
(Date:5/5/2015)... 2015 Synedgen Inc. is pleased to ... Affairs Manager. , Dr. Nguyen brings to Synedgen critical ... the company as it moves forward in the FDA ... next two years. Dr. Nguyen will lead the management ... key documents that must be completed in order to ...
Breaking Biology Technology:Tocagen Appoints David R. Parkinson, M.D., to the Board of Directors 2Tocagen Appoints David R. Parkinson, M.D., to the Board of Directors 3Tocagen Appoints David R. Parkinson, M.D., to the Board of Directors 4GEA Pharma Systems, G-CON Manufacturing and Pfizer Consortium Receives Best Technology Innovation Award at INTERPHEX 2015 2GEA Pharma Systems, G-CON Manufacturing and Pfizer Consortium Receives Best Technology Innovation Award at INTERPHEX 2015 3Synedgen Announces the Appointment of Regulatory Affairs Manager 2
... 4 CV,Therapeutics, Inc. (Nasdaq: CVTX ) ... have entered into an agreement under,which Medlogics has ... develop a drug eluting stent (DES). CV Therapeutics,received ... payments,royalties and other potential payments on future sales ...
... Feb. 4 Intellisphere, publisher of,the MDNG (MD ... announced,today that it has acquired multiple titles from ... presence in several key market,segments and demonstrates its ... and education while providing new opportunities for,associates and ...
... Calif., Feb. 4 /Xinhua-PRNewswire-FirstCall/ --,(OTC Bulletin Board: KWBT) ... Mr. Wei Li, met to discuss cooperative ventures ... Health, Inc. of,Ottawa (Toronto Venture Exchange Symbol: SXS)., ... Mr. Li was Dr. Jianqiang,Zhou who is the ...
Cached Biology Technology:CV Therapeutics and Medlogics Device Corporation Sign Licensing Agreement for CVT's Innovative Stent Coating Technology 2CV Therapeutics and Medlogics Device Corporation Sign Licensing Agreement for CVT's Innovative Stent Coating Technology 3Intellisphere Announces Acquisition of Multiple Titles from Ascend Media's Healthcare Division 2Kiwa Bio-Tech Products Group Discusses Cooperative Efforts With Canadian Agricultural Ministry and Canadian Company 2Kiwa Bio-Tech Products Group Discusses Cooperative Efforts With Canadian Agricultural Ministry and Canadian Company 3
(Date:3/24/2015)... Research and Markets ( http://www.researchandmarkets.com/research/hdgz7h/global_iris ) ... Recognition Market 2015-2019" report to their offering. ... to grow at a CAGR of 23.5 percent over ... present scenario and the growth prospects of the Global ... the market size, the report considers the revenue generated ...
(Date:3/24/2015)... PALM BEACH GARDENS, Fla. , March 24, ... of biometric identity management solutions, today announced that ... enabling premium clothing accessory retailer Goorin Bros ... login. The Crossmatch biometrics-based solution secures access to ... customers from the increased risk of data breaches. ...
(Date:3/23/2015)... , March 23, 2015  In the 2014 ... fraud case conviction losses. This figure accounts for a ... according to The Nilson Report, exceeds $11 billion globally. ... tool after a crime has occurred. Investor Mark ... polygraph expert Joe Paolella partnered to administer ...
Breaking Biology News(10 mins):Global Iris Recognition Market 2015-2019 with 3M Cogent, Bioenable Technologies, Cross Match Technology, Iris ID Systems & Safran Dominating 2Crossmatch Fingerprint Readers Help Retailer Prevent Data Breaches at Point-of-Sale 2Polygraph Test Now Used to Protect Investors From Fraud 2Polygraph Test Now Used to Protect Investors From Fraud 3
... is threatening the time-honored transmission of plant knowledge from ... and nutrition. In a novel study published online this ... Sciences, researchers report that parents, and especially mothers, who ... have healthier children, independent of other factors such as ...
... National Museum of Natural History in Washington, D.C., have ... of what they regard as one of the weirdest ... that the organism was a fungus, the scientists report ... published by the Geological Society of America. Called Prototaxites ...
... long been known that UV light can damage DNA, reducing ... resulting in the development of skin cancers. However, not much ... altered upon exposure to UV light. Now a group of ... changes in the mechanical properties of DNA upon irradiation with ...
Cached Biology News:Mother knows best: Plant knowledge key to childhood health in remote Amazon 2Prehistoric mystery organism verified as giant fungus 2Prehistoric mystery organism verified as giant fungus 3Prehistoric mystery organism verified as giant fungus 4Stretching DNA to the limit 2
... formulated to support the growth of cells ... eucalypti. The medium is a modification of ... cell lines established by Grace using this ... The basal medium, when properly supplemented, has ...
... trays and universal trays make vessel ... Shaking speed: 40 - ... amplitude Clamps for Erlenmeyer ... including Fernbach flasks Hinged ...
...
GLP expression profiling service on the Affymetrix platform. Starting material can be blood, tissue or RNA. 5 day turnaround. Standard and custom post analyses of microarray data available....
Biology Products: