Navigation Links
Reportlinker Adds Biosimilars and Follow-On Biologics: Global Market Outlook 2010-2025 - Opportunities and Challenges in this Emerging Market With High Potential
Date:6/29/2010

lopment of Regulations for the Approval of Biosimilars

4.5.1 Key Issues for Development of Biosimilar Regulations

4.5.2 Requirements for Clinical Trials

4.5.3 Debate over Clinical Trial Requirements in the US

4.5.4 Data Exclusivity Period

4.5.5 Biosimilar Substitution

4.5.6 International Non-Proprietary Names (INNs)

4.6 European Biosimilar Guidelines

4.6.1 EMEA Guidelines for Biosimilar Medicines

4.6.2 Testing Requirements

4.6.3 Clinical Testing For Multiple Indications

4.6.4 Data Exclusivity for Biologic Drugs in the EU

4.6.5 Naming of Biosimilars in the EU

4.6.6 Biosimilar Substitution Not Allowed in the EU

4.6.7 Latest Developments in EMEA Biosimilar Guidelines

4.6.8 Future Development of EMEA Guidelines

4.7 Progress Towards Development of 'Follow-On Protein Products' Regulatory Pathway in the US

4.7.1 Lack of Biosimilar Regulatory Pathway in the US Restricted the Market

4.7.2 Issues Affecting 'Follow-on Protein Products' Legislation in the US

4.7.3 Progress in Development and Implementation of a Biosimilar Regulatory Pathway in the US, 2010

4.8 Biosimilar Regulations in Japan

4.8.1 Japanese Guidelines for Biosimilar Approvals, 2009

4.8.2 Guidelines for the Development of a Biosimilar in Japan


'/>"/>
SOURCE Reportlinker
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18

Related biology technology :

1. Reportlinker Adds Infectious Disease Molecular Diagnostic Testing
2. Reportlinker Adds Smart Glass: Technologies and Global Markets Report
3. Reportlinker Adds Synthetic Biology: Emerging Global Markets Report
4. Reportlinker Adds Proteomics: Technologies and Global Markets Report
5. Reportlinker Adds Nanomedicine Report
6. Reportlinker Adds Small Molecule Kinase Inhibitors Report
7. Reportlinker Adds Nanoporous Materials Report
8. Reportlinker Adds Membrane Bioreactors Report
9. Reportlinker Adds The Future of Orphan Diseases Therapeutics - Market Forecasts to 2015, Pipeline Analysis and Reimbursement
10. Reportlinker Adds High-Tech Patient Monitoring Systems Markets (Remote and Wireless Systems, Data Processing, EMR Data Transfer) Report
11. Reportlinker Adds In Vitro Diagnostics in a Recession: IVD Market Forecasts, Analysis and Success Strategies Report
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/29/2014)... NY (PRWEB) August 29, 2014 Local ... Hills Veterinary Hospital are seeking candidates to participate in ... with osteoarthritis. The ultimate goal of this study ... stem cells into one or two arthritically affected joints ... joints. , Candidates for the current investigational study ...
(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)... Spin-charge converters are important devices in spintronics, an ... charge of electrons but also on their spin ... transformation of electric into magnetic signals and vice ... Sinova from the Institute of Physics at Johannes ... the UK, Prague, and Japan, has for the ...
(Date:8/28/2014)... 28, 2014 Sterlitech is proud to ... to its stable of products . These ... cut-offs and include membrane filters with surface charges. ... customer demand for our membrane process testing equipment, and ... flat sheet membranes,” explains Sterlitech President Mark Spatz. ...
Breaking Biology Technology:Burnt Hills Veterinary Hospital Seeks Candidates for an Investigational Study of Stem Cells for Dogs with Arthritis 2Glenn Boreman, UNC Professor and Plasmonics Co-Founder, Elected to SPIE Presidential Chain 2A new, tunable device for spintronics 2A new, tunable device for spintronics 3Sterlitech Corporation Enhances Its Selection of Flat Sheet Membrane Filters 2
... an economic year in which some new investments were made, ... positioned itself to prosper in some emerging sectors. , ,With ... must remain warm and state policymakers need to turn a ... compete in the global marketplace. What's in store for the ...
... The Dow Jones Industrials had a fabulous year ... had a very solid year, by a large margin. The ... differently, mostly because the different composition of each. , ,The ... represents a greater spectrum of the biotech industry (larger and ...
... Wis. - The United States District Court for the ... damage verdict against Abbott Laboratories . , ,The Madison-based ... biopharmaceutical company based in Gent, Belgium, and rejected Abbott Labs' ... sued Abbott labs for infringing on a genotyping patent. Frank ...
Cached Biology Technology:Wisconsin's high-growth economy: '07 predictions 2Wisconsin's high-growth economy: '07 predictions 3Wisconsin's high-growth economy: '07 predictions 42006: A mixed blessing for Midwest life science companies 22006: A mixed blessing for Midwest life science companies 32006: A mixed blessing for Midwest life science companies 42006: A mixed blessing for Midwest life science companies 52006: A mixed blessing for Midwest life science companies 62006: A mixed blessing for Midwest life science companies 72006: A mixed blessing for Midwest life science companies 82006: A mixed blessing for Midwest life science companies 92006: A mixed blessing for Midwest life science companies 102006: A mixed blessing for Midwest life science companies 11
(Date:8/29/2014)... the University of Texas Medical Branch at Galveston has gone ... can completely protect monkeys against a lethal dose of Ebola ... when the disease is severe. , Thomas Geisbert, professor of ... discussing advances in Ebola treatment research. The filoviruses known ... deadly of pathogens, with fatality rates of up to 90 ...
(Date:8/29/2014)... release is available in German . ... players in the natural nitrogen cycle on Earth and ... bacteria were thought to depend on nitrite as their ... by Holger Daims, a microbiologist at the University of ... hydrogen as an alternative source of energy. The oxidation ...
(Date:8/29/2014)... - In a cell,s nucleus, chromosomal DNA is ... an amalgam biologists call chromatin. Until about two ... "sidekick," the mere packing material around which the ... have developed a greater appreciation for how DNA/histone ... from multiple research institutions studying the sequence of ...
Breaking Biology News(10 mins):Leading Ebola researcher at UTMB says there's an effective treatment for Ebola 2Hydrogen powers important nitrogen-transforming bacteria 2Hydrogen powers important nitrogen-transforming bacteria 3'K-to-M' histone mutations: How repressing the repressors may drive tissue-specific cancers 2'K-to-M' histone mutations: How repressing the repressors may drive tissue-specific cancers 3
... vanilla smells like vanilla. But androstenone, a derivative of ... odor, can smell like either - depending on your ... androstenone, usually that of stale urine or strong sweat, ... cannot smell it at all. New research ...
... that plays a linchpin role in the ability of ... may lead to improved therapies for hormone-responsive breast cancers ... treatments. Estrogen causes hormone-responsive breast cancer cells to ... by cancer cells. Interfering with estrogen signaling is the ...
... sensor of voltage-gated ion channels is a conserved protein ... regulate ion permeation through the channel. A recently discovered ... not to an ion channel but to a phosphatidylinositide ... In a new paper published in The Journal ...
Cached Biology News:Gene determines whether male body odor smells pleasant 2Gene determines whether male body odor smells pleasant 3Linchpin gene may be useful target for new breast cancer therapies 2New insight into the mechanisms of voltage sensing and transduction in biological processes 2
... Diessel fermentation systems for cultivation of microorganisms ... manufacturers of bio-pharmaceutical products maximum performance and ... microbial and cell fermentation 10 L ... areas ,*Fully automated control system ...
... Feature Extraction Software reads and ... to prepare microarray data for ... * one 1-year license ... NFP/Academic accounts ,one CD-ROM containing ...
... ELF 97 Cytological Labeling Kit provides a ... detection of cellular targets, including cell-surface receptors ... Labeling Kit contains the patented ELF 97 ... yellow-green precipitate at the site of enzymatic ...
... the various commercial and lab-prepared glass arrays. ... length and GC content of the attached ... employed all influence the optimal hybridization conditions ... the different variables to consider, it is ...
Biology Products: