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:12/19/2014)... 18, 2014 Egenix, Inc. is pleased to announce ... of the Board, to succeed Donald Fresne ; Mr. ... continue as a member of the Board.  In recognition of ... the company over almost twenty years, the Board designated Mr. ... Directors has established a Search Committee to find a suitable ...
(Date:12/17/2014)... Washington, USA (PRWEB) December 16, 2014 ... Baum, manager at Philipps- Universität Marburg’s Department of ... and photonics, in the newly released SPIE ... “And never be too shy to ask questions.” ... (science, technology, engineering, and mathematics) occupations ranging from ...
(Date:12/17/2014)... 2014 Xeno Diagnostics has again ... most recent COLA inspection. Xeno has met all ... healthcare accreditation organization. Accreditation is earned only by ... day-to-day operations, demonstrate continued accuracy in the performance ... laboratory survey. , While the Laboratory ...
(Date:12/17/2014)... Md. , Dec. 17, 2014 CASI ... company dedicated to the acquisition, development and commercialization of ... for the global market with a primary commercial focus ... it has been granted a Type C meeting with ... the meeting will be held in February 2015.  During ...
Breaking Biology Technology:Network, Multitask, Persevere: SPIE Women in Optics Planner Subjects Share from Experience 2Network, Multitask, Persevere: SPIE Women in Optics Planner Subjects Share from Experience 3Xeno Diagnostics Receives 3rd Award for Laboratory Excellence 2CASI Pharmaceuticals Granted Type C Meeting With U.S. FDA For ENMD-2076 In Fibrolamellar Carcinoma 2CASI Pharmaceuticals Granted Type C Meeting With U.S. FDA For ENMD-2076 In Fibrolamellar Carcinoma 3CASI Pharmaceuticals Granted Type C Meeting With U.S. FDA For ENMD-2076 In Fibrolamellar Carcinoma 4CASI Pharmaceuticals Granted Type C Meeting With U.S. FDA For ENMD-2076 In Fibrolamellar Carcinoma 5
... As ... accurately forecast, plan and respond to ever-changing market demands, ManufacturingOne meets the needs of ... ... a growing customer base in the high-tech manufacturing segment, YASH Technologies, a leading ...
... ... ... -- invivodata inc. , the industry leader in patient reported outcomes (PRO) solutions ... PRO Consulting , today announced a limited time, complimentary PRO Gap Analysis service to ...
... ... The International Marketplace. , ... (PRWEB) March 24, 2010 -- Sterlitech Corporation, one of the world’s leading producers ... prestigious Faces of Trade® Award presented by the US Chamber of Commerce. , ...
Cached Biology Technology:YASH Technologies™ Launches ManufacturingOne, a Qualified SAP Business All-in-One Partner Solution for the High-tech Manufacturing Industry 2YASH Technologies™ Launches ManufacturingOne, a Qualified SAP Business All-in-One Partner Solution for the High-tech Manufacturing Industry 3YASH Technologies™ Launches ManufacturingOne, a Qualified SAP Business All-in-One Partner Solution for the High-tech Manufacturing Industry 4invivodata Offers Complimentary PRO Gap Analysis 2invivodata Offers Complimentary PRO Gap Analysis 3US Chamber Of Commerce Honors Sterlitech Corporation 2
(Date:12/11/2014)... , Dec. 09, 2014 Research and Markets ... ( http://www.researchandmarkets.com/research/9ql3kr/biometrics_market ) has announced ... India 2015-2019" report to their offering. ... market is the adoption of multimodal biometric systems. ... of an individual for verification and identification purposes. ...
(Date:12/10/2014)... 2014 You,ve been here before: you desperately need ... your password, site key or the answer to your secret ... teacher? Today, Hoyos Labs , a ... will finally put an end to the frustration that comes ... . 1U leverages a user,s smartphone to acquire his or ...
(Date:12/10/2014)... , Dec. 9, 2014 CIE San ... catalyst that provides the connective tissue that enhances care ... them to easily share client-level information; earned a second ... expand to organizations serving seniors aging in community and; ... partner on December 11 th 4-6p. ...
Breaking Biology News(10 mins):Biometrics Market in India 2015-2019: Key Vendors are 3M Cogent, NEC, Safran and Suprema 2The Password is Finally Dead: Launch of 1U Mobile App Eliminates Need for All Usernames and Passwords 2The Password is Finally Dead: Launch of 1U Mobile App Eliminates Need for All Usernames and Passwords 3Community Information Exchange San Diego Launches Pilot, Secures $1 Million Expansion Grant, and Becomes a "Live Well San Diego" Partner 2Community Information Exchange San Diego Launches Pilot, Secures $1 Million Expansion Grant, and Becomes a "Live Well San Diego" Partner 3Community Information Exchange San Diego Launches Pilot, Secures $1 Million Expansion Grant, and Becomes a "Live Well San Diego" Partner 4
... trillions of cells, all derived from a single cell, or zygote, ... single cell contains all the genetic information needed to develop into ... new cell as it divides into the many diverse types of ... If each cell is genetically identical, however, how does ...
... make sure their children drink milk and eat other calcium-rich foods ... make sure their kids eat salmon, almonds and other foods high ... in bone health, according to a study to be presented Sunday, ... Washington, DC. "Lots of nutrients are key for children ...
... and/or improve the quality of life for many cancer patients. ... inducing damage to DNA. The public has an opportunity ... used anticancer drugs and how laboratory research may lead to ... Yinsheng Wang , a professor of chemistry at ...
Cached Biology News:Divide and define: Clues to understanding how stem cells produce different kinds of cells 2Divide and define: Clues to understanding how stem cells produce different kinds of cells 3Magnesium may be as important to kids' bone health as calcium 2How do anticancer drugs work? 2How do anticancer drugs work? 3
... a cytochrome P450 (CYP450) metabolite postulated to ... and cerebral vasculature. In rat cerebral microvessels, ... autoregulatory vasoconstriction. 20-HETE is excreted mainly as ... 20-HETE (20-40 pg/ml in human urine) is ...
Contact us for more information...
Rabbit polyclonal to Quinaldic Acid ( Abpromise for all tested applications). Antigen: Synthetic peptide Quinaldic Acid conjugated to a protein carrier....
... kinase (JNK) is one of the several ... been used as a sensitive reporter for ... a 1000-fold increase in sensitivity in comparison ... Firefly luciferase catalyzes the oxidative carboxylation of ...
Biology Products: