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:1/15/2014)... January 15, 2014 The Pittcon Organizing Committee ... Food Safety Tech , an e-Journal and producer of ... agreement for the second year for the co-location of Food ... The partnership provides that the registration fee to attend the ...
(Date:1/15/2014)... and SAN JOSE, California , January ... company developing antibody-drug conjugates for cancer, today announced the appointment ... Directors. Dr Reynolds has over 20 years, development experience gained ... at Seattle Genetics. "I am delighted to welcome ...
(Date:1/15/2014)... 15, 2014 More than 5 million ... 1 in 3 seniors will die with Alzheimer’s or ... jaw-dropping figures have shocked many Americans into looking for ... prevent these tragic age-related cognitive disorders. Jonathan Weisman, president ...
(Date:1/15/2014)... 15, 2014 2013 was a banner ... State Technologies®. They saw continued independent research led by ... were awarded a $1 million grant from the Susanne ... and Behavior” a peer reviewed journal, Amy Grant highlighted ...
Breaking Biology Technology:Pittcon Announces Second Year Partnership With Food Safety Tech 2Pittcon Announces Second Year Partnership With Food Safety Tech 3Oxford BioTherapeutics Appoints Thomas C Reynolds MD, PhD to its Board of Directors 2Oxford BioTherapeutics Appoints Thomas C Reynolds MD, PhD to its Board of Directors 3Biohack Pure Offers 5 Tips for Increasing Memory in 2014 2Dynamic Innovative Technology Showcased at Scottsdale Company’s Open House 2Dynamic Innovative Technology Showcased at Scottsdale Company’s Open House 3
... important parameters for optimizing electroporation., , , , , , , ... Pulse length , , ... Adjustment , of the electroporation buffer , ... , of temperature , Influence , ...
... and the Brinkmann Bottletop Buret , ... , Bottletop dispensers are used in the lab for dispensing ... or stainless steel containers. These dispensers , have to ... substances which may disturb trace analysis, have cytotoxic properties, , ...
... , Sample Preparation: , ... washed and pelleted cultured cells, add 200 , l 4 ... Sodium Citrate, pH 7.0, 1 M b-Mercaptoethanol) , to 0.5 ... To directly extract RNA from cultured cells growing in monolayer, , ...
Cached Biology Technology:Optimizing electroporation parameters 2Chemical Stability of the Brinkmann Bottletop Dispenser , and the Brinkmann Bottletop Buret 2Chemical Stability of the Brinkmann Bottletop Dispenser , and the Brinkmann Bottletop Buret 3Chemical Stability of the Brinkmann Bottletop Dispenser , and the Brinkmann Bottletop Buret 4Chemical Stability of the Brinkmann Bottletop Dispenser , and the Brinkmann Bottletop Buret 5Chemical Stability of the Brinkmann Bottletop Dispenser , and the Brinkmann Bottletop Buret 6Chemical Stability of the Brinkmann Bottletop Dispenser , and the Brinkmann Bottletop Buret 7Chemical Stability of the Brinkmann Bottletop Dispenser , and the Brinkmann Bottletop Buret 8Chemical Stability of the Brinkmann Bottletop Dispenser , and the Brinkmann Bottletop Buret 9Chemical Stability of the Brinkmann Bottletop Dispenser , and the Brinkmann Bottletop Buret 10Chemical Stability of the Brinkmann Bottletop Dispenser , and the Brinkmann Bottletop Buret 11Chemical Stability of the Brinkmann Bottletop Dispenser , and the Brinkmann Bottletop Buret 12Chemical Stability of the Brinkmann Bottletop Dispenser , and the Brinkmann Bottletop Buret 13Chemical Stability of the Brinkmann Bottletop Dispenser , and the Brinkmann Bottletop Buret 14Chemical Stability of the Brinkmann Bottletop Dispenser , and the Brinkmann Bottletop Buret 15Chemical Stability of the Brinkmann Bottletop Dispenser , and the Brinkmann Bottletop Buret 16Chemical Stability of the Brinkmann Bottletop Dispenser , and the Brinkmann Bottletop Buret 17Chemical Stability of the Brinkmann Bottletop Dispenser , and the Brinkmann Bottletop Buret 18Chemical Stability of the Brinkmann Bottletop Dispenser , and the Brinkmann Bottletop Buret 19Chemical Stability of the Brinkmann Bottletop Dispenser , and the Brinkmann Bottletop Buret 20Chemical Stability of the Brinkmann Bottletop Dispenser , and the Brinkmann Bottletop Buret 21Chemical Stability of the Brinkmann Bottletop Dispenser , and the Brinkmann Bottletop Buret 22Chemical Stability of the Brinkmann Bottletop Dispenser , and the Brinkmann Bottletop Buret 23Chemical Stability of the Brinkmann Bottletop Dispenser , and the Brinkmann Bottletop Buret 24Chemical Stability of the Brinkmann Bottletop Dispenser , and the Brinkmann Bottletop Buret 25Chemical Stability of the Brinkmann Bottletop Dispenser , and the Brinkmann Bottletop Buret 26Total RNA Isolation Protocol 1,2,3 2Total RNA Isolation Protocol 1,2,3 3
(Date:4/22/2014)... Inspired by the fist-like club of a ... of California, Riverside, in collaboration with University of Southern ... for composite materials that is more impact resistant and ... more we study the club of this tiny crustacean, ... many things we use every day," said David Kisailus, ...
(Date:4/22/2014)... Scientists at the University of Massachusetts Amherst and ... this week report that they have discovered a new ... of the Negro River in the Amazonia State of ... with Adlia Nogueira and Jos Antnio Alves-Gomes of INPA, ... of the journal Proceedings of the Natural Sciences ...
(Date:4/22/2014)... for Experimental Biology (FASEB) has released updated factsheets ... from the National Institutes of Health (NIH) benefits each ... is pleased to make these factsheets available to help ... their state," said FASEB President, Margaret K. Offermann, MD, ... research funding, investing $29.2 billion in FY 2013 ...
Breaking Biology News(10 mins):Mantis shrimp stronger than airplanes 2Mantis shrimp stronger than airplanes 3New electric fish genus and species discovered in Brazil's Rio Negro 2
... COMO, ITALY -- Traditionally addressed through hand-weeding and/or herbicide ... in nursery production. Increased labor costs have made hand-weeding ... although herbicides may be effective and less expensive, non-target ... can harm the environment. To address the economic and ...
... is pleased to announce a mobile-optimized web interface for ... Journal of Experimental Biology and Disease Models & Mechanisms. ... Biology Open , will also be available as a ... increasing number of our readers want to access journal ...
... Li Qian, PhD, has won the Louis N. and ... Investigators from the American Heart Association (AHA), marking the ... Gladstone Institutes researcher has been the recipient. ... a leading and independent biomedical-research organization -- and a ...
Cached Biology News:Biodegradable mulches successfully control weeds in container-grown arborvitae 2Gladstone scientist receives American Heart Association's Katz prize for cardiovascular research 2
Loading Buffer...
"BioTracker 6X Bromophenol Blue Tracking Dye is composed of 60% St DI H2O, 30% Glycerol, 10% 10XTE, 0.25% BPB Dye and 0.85% SDS....
Request Info...
Request Info...
Biology Products: