Navigation Links
PAREXEL Consulting Thought Leaders Provide Insights Into U.S. Biosimilar Development and Monoclonal Biosimilars in Two New White Papers
Date:9/22/2010

Food and Drug Administration (FDA) to discuss biosimilar product development programs.  According to Dr. Babbitt, a well-defined regulatory pathway for biosimilars has been operating in Europe since 2005, and the U.S. is now poised to enter this marketplace.  As noted in the white paper, the FDA is planning to spend $5.7 million in Fiscal 2011 to develop drug review standards specific for biosimilars.  In addition, key aspects of the legislation are discussed as well as how biosimilarity and potentially interchangeability to innovator products is to be demonstrated.

"How Can the Biosimilar Concept Be Applied to More Complex Proteins Such as Monoclonals?" further examines the potential development of biosimilar versions of approved mAbs. The white paper addresses the robustness of the mAb market, which is anticipated to increase at a compound annual growth rate of nearly 11 percent, and discusses approval pathways for biosimilar mAbs that could propel the biosimilars market. The white paper reviews the complex structure of mAbs, the value of nonclinical data, new thinking required in early development and the challenges of confirmatory efficacy trials.

"Demonstrating therapeutic equivalence for monoclonals will be challenging and companies will need to consider their options carefully," said Mr. Nick. "The biosimilar industry along with regulators will need to apply state of the art methodologies and novel approaches for biosimilar monoclonals to become a reality."

The white papers, part of PAREXEL Consulting's Intelligent Development Series, which provides data and insights in support of successful biopharmaceutical and medical device product development, are available at: http://www.PAREXEL.com/services-and-capabilities/consulting/our-thinking/whitepapers.

About PAREXEL International PAREXEL International Corpor
'/>"/>

SOURCE PAREXEL International Corporation
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. PAREXEL Announces Strategic Functional Service Provider Relationship with Eli Lilly and Company for Clinical Development in Asia/Pacific Region
2. PAREXEL Introduces Temperature Recording Solution for Study Drug Transportation, Bringing More Efficiency to Clinical Supply Chain
3. PAREXEL Expert To Lead Panel on Innovative Drug Development in Asia at Partnerships in Clinical Trials Asia Pacific Conference
4. PAREXEL Enhances Early Phase Cardiac Safety Capabilities Through Alliance With Mortara Instrument
5. PAREXEL Reports First Quarter Fiscal Year 2010 Financial Results
6. PAREXEL International to Present at William Blair Emerging Growth Stock Conference
7. PAREXEL Reaches Milestone in Management of Oncology Trials Over Last Five Years Involving 175,000 Patients Worldwide
8. PAREXEL Strengthens Leading Presence in Latin America With a New Location in Peru
9. PAREXEL Data Reveal A Record High Number of Clinical Trials Initiated
10. PAREXEL Expands Global Clinical Pharmacology Capabilities
11. PAREXEL Expands Late Phase Clinical Research Services and Appoints Leading Pharmacoepidemiology Expert Victor Kiri
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/28/2015)... , Aug. 28, 2015 ... addition of the "Investigation Report on China,s Tobramycin ... Tobramycin is a traditional antibiotic whose eye drop and ... treatment of potential infection or inflammation caused by eye ... are able to produce tobramycin, among which ...
(Date:8/28/2015)... , Aug. 28, 2015 Patterson Medical, ... (Nasdaq: PDCO ), is now an independent ... acquisition of Patterson Medical by Madison Dearborn Partners ... its name for a transition period before rebranding ... and sports medicine products.  With the focused resources ...
(Date:8/28/2015)... , Aug. 28, 2015 ... announced the addition of the "Investigation Report ... to their offering. Developed by Novo ... Novolog) is an important drug for the treatment ... as a fast- acting insulin analog, starts working ...
Breaking Medicine Technology:Investigation Report on China's Tobramycin Market, 2015-2019 2Patterson Medical Positioned for Continued Growth as a Newly Independent Company 2Patterson Medical Positioned for Continued Growth as a Newly Independent Company 3China Insulin Aspart Market Report 2010-2019 - Developed by Novo Nordisk 2
... , MT. LAUREL, N.J., Dec. 1 ... of technology-enabled clinical documentation services, today announced that the radiology ... SpeechQ for Radiology(TM), MedQuist,s real-time speech recognition system. The solution ... (RSNA) convention November 29 through December 2. ...
... , PISCATAWAY, N.J., Dec. 1 Siemens ... hearing instruments, announced its third annual partnership with Quota International,s ... 2010. , As part of the renewed partnership, Siemens is ... instruments to both children and young adults, age 23 years ...
Cached Medicine Technology:MedQuist Integrates Search Engine from Primordial with SpeechQ(TM) for Radiology 2Siemens Hearing Instruments Renews Quota Partnership to Give the Gift of Hearing to Children and Young Adults in Need 2Siemens Hearing Instruments Renews Quota Partnership to Give the Gift of Hearing to Children and Young Adults in Need 3
(Date:8/28/2015)... Columbus, Ohio (PRWEB) , ... August 28, 2015 ... ... Saturday’s Imagine No Malaria Day at the Zoo to celebrate children helping children, ... people and their congregations throughout West Ohio have contributed to the United Methodist ...
(Date:8/28/2015)... ... , ... For Dallas, the time is nearing for the annual Heart Walk, ... , The American Heart Association hosts their well-known Heart Walk to raise money in ... difference can be made. Walkers can participate in the cause and someone can also ...
(Date:8/28/2015)... ... August 28, 2015 , ... On May 30th, 2015, Best Drug Rehabilitation, ... the “Music With A Mission” benefit concert in Mendon, IL. Held in the Show ... money to support music education programs in the underfunded local school districts of Mendon ...
(Date:8/28/2015)... ... August 28, 2015 , ... ... documenting and diagramming network and data center assets and audio-video devices, recently released ... Cisco Nexus 5000 Series, HP ProLiant Gen9, EMC VNX Series , Super Micro ...
(Date:8/28/2015)... Utah (PRWEB) , ... August 28, 2015 , ... ... awarded a three-year accreditation for its adolescent residential, counseling, day treatment and intensive ... that it meets international standards for quality and its pursuit of excellence. As ...
Breaking Medicine News(10 mins):Health News:Saturday’s United Methodist Event at Columbus Zoo Celebrates Imagine No Malaria 2Health News:Saturday’s United Methodist Event at Columbus Zoo Celebrates Imagine No Malaria 3Health News:North Central Surgical Center’s Subsidiary Participates in Walk 2Health News:New Video Released on "Music With A Mission" Benefit Concert Headlining Artist Cadillac Three & Best Drug Rehabilitation 2Health News:Altima Updates NetZoom™ Visio® Stencil Library for Cisco, HP, and EMC Devices 2Health News:Altima Updates NetZoom™ Visio® Stencil Library for Cisco, HP, and EMC Devices 3Health News:West Ridge Academy Awarded CARF Three-Year Accrediation 2
... for tuberculosis has revealed that nearly 40% of the doctors ... levels// in those who work in TB clinics. The research ... is a growing problem worldwide. Russia is one country where ... the world's population are infected with the bacterium that causes ...
... breast cancer therapy drug tamoxifen, to another one exemestane//, could ... their findings in the online version of The Lancet, researchers ... and team, stood for changing treatments tracks to exemestane after ... reduced deaths by 17 percent. ,Their findings stem ...
... drug that aids patients who suffer from persistent iron overload ... ,Patients suffering from a rare genetic condition or ... transfusions. Generally these people are given a painful infusion at ... hours. ,But the new drug Exjade is an ...
... Carnegie Institution's Department of Plant Biology have discovered ... regulation—neighboring pore-like structures at the cell's surface physically ... nutrient, nitrogen. It is the first time scientists ... is essential to this regulation. Since plants, animals, ...
... new technique that uses ozone to preserve grapes could help ... reports Jennifer Rohn in Chemistry & Industry, the magazine of ... wine-making process to produce healthier wines without the added sulphites ... ,Mass-marketed grapes can remain in storage for months ...
... research currently underway brings hope of dramatic advances ... review//. The review reveals that new approaches in ... chemotherapy, and research on breast cancer vaccines may ... physician treating breast cancer patients. These new tools ...
Cached Medicine News:Health News:New Drug Therapy for Breast Cancer Offers Hope 2Health News:New Mechanism for Nutrient Uptake Discovered 2Health News:New Mechanism for Nutrient Uptake Discovered 3Health News:Grape Expectations for Healthier Wine 2Health News:Emerging Research Heralds New Era of Breast Cancer Management 2
Welch Allyn introduced halogen HPX lamp technology to provide 30% more light output than previous halogen lamps. The mix of halogen and xenon gases provide whiter, longer lasting light - making your ...
RT-600 Refractor...
... Ultramatic Rx Master is designed ... of reliable service and give ... measurably improve procedures. It embodies ... and want most, including accuracy, ...
Occluder and Maddox Rod...
Medicine Products: