Navigation Links
Pathway for Biosimilars Act Protects Patients, Promotes Competition, Preserves Innovation and Creates Quality Jobs, Lilly Says
Date:3/17/2009

l new biological drugs a base period of 12 years of data protection with the right to obtain an additional two years once a further indication for use of the product is approved by the FDA.

Today, strong patents, when they exist, can protect all types of medicines from competition, including protection from generic copies. However, effective patent protection is sometimes unavailable or available only for a very limited period once a new medicine gets to market. In both these situations, patent protection by itself can be insufficient to secure a fair return on the research investments needed to get the new medicine to market - thus risking the system by which new cures and treatments are found. These and other patent shortcomings are magnified for biological drugs because of their relative complexity and the greater uncertainty in how patent laws will eventually apply to them.

In addition to strong patents, "data protection" would offer additional needed protections for innovative biological medicines. Data protection, unlike patents, sets out a consistent, defined period in which copied versions of a new biological drug can only come to market if it follows the same rigorous testing requirements that the innovator undertook to gain FDA approval.

Thus, through an adequate period of data protection, patients and their physicians can be assured of a more complete safety and effectiveness track record before "follow-on" or biosimilar products come to market - important because of consistency and purity concerns. Significantly, Eshoo-Inslee-Barton's approach to data protection is consistent with the earlier Senate-approved approach.

Armitage noted that the biotech industry that creates life-saving biologic medicines boosts the U.S. economy and provides high-paying American jobs. According to the Bureau of Labor Statistics, the biosciences sector is expected to add 69,000 U.S. manufacturing
'/>"/>

SOURCE Eli Lilly and Company
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Biogenerics Legislation Provides Critical Pathway to Affordable Access for Patients with Chronic and Complex Conditions
2. Bavarian Nordic Has Essentially Agreed a Pathway for the Licensure of IMVAMUNE(R) With the FDA After Successful End of Phase II Meeting
3. Millipore Launches an Interactive Biological Pathway Tool Using GeneGos Manually Curated Pathway Maps
4. Cardiovascular Side Effects of Pioglitazone and Rosiglitazone Linked to Vascular and Energy Pathways by Genomas Clinical Study
5. GEN Reports Growing Focus on PI3-Kinase Pathway in Cancer Research
6. Debiopharm and Aurigene Sign Licensing Agreement for the Development and Commercialisation of Debio 0617, a Novel Inhibitor of an Undisclosed Oncology Pathway
7. Frost & Sullivan Awards Genpathway 2008 Healthcare Innovation Award
8. Trillium secures additional financing on the strength of lead program and proprietary position around the CD200 immunoregulatory pathway
9. Pathway Diagnostics Announces Commercial Availability of Second Generation SensiTrop(TM) II Molecular HIV Co-receptor Tropism Assay
10. Study Suggests GAMMAGARD LIQUID May Target the Primary Pathway Involved in Alzheimers Disease
11. Ingenuity Systems and Pfizer Announce Strategic Partnership for Pathway Analysis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/31/2015)... 2015 In today,s fast changing healthcare ... drive positive health outcomes, improve profitability and enhance ... care in their communities. At ThoughtSpot 2015, ... AmerisourceBergen announced a new set of innovative capabilities ... and help independent pharmacies endure the industry,s most ...
(Date:7/31/2015)... ... July 31, 2015 , ... Global Resorcinol Market 2015-2019 is ... on the global resorcinol industry. The report highlights the various growth prospects and ... and analysis of primary and secondary inputs from the existing players of the ...
(Date:7/31/2015)... , July 31, 2015 China Cord ... China,s leading provider of cord blood ... cell storage services, today announced that the Company has ... U.S. Securities and Exchange Commission. The filed Form 20-F ... March 31, 2015. The Form 20-F can be accessed ...
(Date:7/31/2015)... ... July 31, 2015 , ... R-Biopharm is proud to ... hydrolyzed gluten in foods, has been accepted by AOAC International as Official First ... in Fermented Cereal-Based Products by R5 Competitive ELISA,” based on a specific monoclonal ...
Breaking Biology Technology:AmerisourceBergen Unveils Suite of Enhanced Capabilities for Independent Pharmacies at ThoughtSpot 2015 2AmerisourceBergen Unveils Suite of Enhanced Capabilities for Independent Pharmacies at ThoughtSpot 2015 3Resorcinol Market to Grow at 6% CAGR to 2019 Says New Research Report at ReportsnReports.com 2Resorcinol Market to Grow at 6% CAGR to 2019 Says New Research Report at ReportsnReports.com 3Resorcinol Market to Grow at 6% CAGR to 2019 Says New Research Report at ReportsnReports.com 4China Cord Blood Corporation Files Its Annual Report on Form 20-F 2RIDASCREEN® Competitve Gliadin Receives AOAC Official First Action Status 2
... In a column I wrote last year, I alluded to ... global. In fact, there are now 4,284 biotech companies in 25 ... , ,Moreover: , , The biotech industry has 622 publicly ... $16 billion in R&D in 2001. , , The industry ...
... of industry, government, and more than 200 universities ... University), Internet2 is leading the way toward revolutionary ... effective access to Internet2s main infrastructure is still ... and Director of the Division of Information ...
... The University of Wisconsin-Madisons Education Building, which originally ... been unfinished for 104 years, but thanks to ... modernize and complete the building, one of Bascom ... Tashia F. Morgridge, both UW-Madison alumni, hope the ...
Cached Biology Technology:In Globalizing Biotech, Midwest Must Differentiate From Pack 2In Globalizing Biotech, Midwest Must Differentiate From Pack 3In Globalizing Biotech, Midwest Must Differentiate From Pack 4From the back roads to the superhighway: Making the connection to Internet2 2Cisco Chairman donates $31 million for UW building renovation 2
(Date:7/31/2015)... Kina, 31. juli 2015 Den 10. internationale ... af BGI fra den 22. - 25. oktober i ... fejrer sin 10-års fødselsdag i år. Siden starten i ... årlige møder på ,omik,-feltet, og er en af de ... ICG-10 fokuserer på nylige gennembrud og fremskridt inden ...
(Date:7/31/2015)... 2015 BGI llevará a cabo la 10ª Conferencia ... 25 de octubre de 2015, en Shenzhen, ... décimo aniversario este año. Desde su inauguración en 2006, ... anuales más influyentes del mundo en los campos de ... más dinámicas, entusiastas y amenas. ICG-10 se ...
(Date:7/31/2015)... , 31 de julho de 2015 ... www.icg-10.org ) será realizada pela BGI de 22-25 de ... . A conferência está celebrando seu 10 ... 2006, a ICG se tornou uma das reuniões mais ... dos encontros científicos mais dinâmicos, entusiastas e prazerosos. ...
Breaking Biology News(10 mins):Den 10. internationale konference om Genomics (ICG-10) åbner i oktober 2La 10ª Conferencia Internacional sobre Genómica (ICG-10) comienza en octubre 2La 10ª Conferencia Internacional sobre Genómica (ICG-10) comienza en octubre 3A 10a. Conferência Internacional sobre Genômica (ICG-10) será em outubro 2A 10a. Conferência Internacional sobre Genômica (ICG-10) será em outubro 3
... April 14, 2011 A natural hormone known to inhibit ... Medical Center researchers have demonstrated. Scientists led by Dr. ... the anti-aging hormone Klotho suppressed both renal fibrosis a ... of cancer. The findings are available online in the ...
... following highlights summarize research papers that have been recently published ... Little Ice Age resulted from more than just solar calm ... the amount of light the Sun puts out, varies with ... TSI is notably higher or lower than its average values. ...
... and toad skins already are renowned as cornucopias of ... ACS,s Journal of Proteome Research reveals that ... antibacterial and antiviral substances that could inspire a new ... out that scientists know little about the germ-fighting proteins ...
Cached Biology News:Anti-aging hormone Klotho inhibits renal fibrosis, cancer growth 2AGU journal highlights -- April 13, 2011 2AGU journal highlights -- April 13, 2011 3AGU journal highlights -- April 13, 2011 4AGU journal highlights -- April 13, 2011 5AGU journal highlights -- April 13, 2011 6AGU journal highlights -- April 13, 2011 7
Amino-acids and Derivatives Rabbit Anti-conjugated L-isoleucine Polyclonal Antibody...
Phosphatidylinositol transfer protein beta isoform (PtdIns transfer protein beta) (PtdInsTP) (PI-TP-beta). [Source:Uniprot/SWISSPROT;Acc:P48739] Antigen: Recombinant Protein Epitope Signature Tag...
Anti-MMP-25 (Membrane-type MMP-6, Mt6MMP), hinge region; rabbit host...
Mouse monoclonal [88B] to nicotinic Acetylcholine Receptor ( Abpromise for all tested applications)....
Biology Products: