Navigation Links
Biosimilars Need Same Names as Original Biologics, Hospira Says at World Health Organization (WHO) Meeting
Date:10/22/2013

LAKE FOREST, Ill., Oct. 22, 2013 /PRNewswire/ -- Hospira, Inc. (NYSE: HSP), the world's leading provider of injectable drugs and infusion technologies, said at the World Health Organization (WHO) today that biosimilar drugs should be given the same nonproprietary names as original biologics to ensure patient access and safe prescribing.

Sumant Ramachandra, M.D., Ph.D., senior vice president and chief scientific officer, Hospira, spoke at the WHO's 57th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland, and made the following points:

  • Europe has approved biosimilars with the same nonproprietary names as their reference biologics for more than six years in a system that has proved effective
  • Biosimilars have been successfully tracked in the marketplace using their brand name, meaning a separate nonproprietary name isn't necessary for keeping track of biosimilars once they're on the market
  • The U.S. Affordable Care Act (ACA), under which Congress gave the U.S. Food and Drug Administration (FDA) a pathway to approve biosimilars, didn't include any language requiring separate nonproprietary names for biosimilars
  • Different nonproprietary names for a biologic and the biosimilar product modeled from it could create confusion among the clinicians who rely on international and local standards to fill prescriptions for patients, potentially resulting in safety and medication access issues

Dr. Ramachandra, who spoke at WHO on behalf of the Generic Pharmaceuticals Association (GPhA), recently authored a

SOURCE Hospira, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Immune Deficiency Foundation Urges FDA To Exempt Immunoglobulin From Biosimilars Pathway
2. Despite Recession, Global Biosimilars Market Grew Over 40% 2010-2011, Set to Reach $3.6 Billion by 2016
3. Biosimilars: Global Markets
4. UBM Conferences Unveils Details for Upcoming Generics and Biosimilars Conference
5. FDA New Guidelines for Biosimilars and Biobetters: An Outlook for 2013
6. Biosimilars Market Expected to Soar
7. Viropro and Oncobiologics Sign Emerging Markets Biosimilars Deal
8. XBiotech Expands Portfolio to Include Biosimilars
9. Recall of Anemia Drug Omontys Rings Alarm Over Biosimilars
10. Seminar Spotlights Key Trends in Biologics and Biosimilars
11. Competitor Analysis: Therapeutic Proteins - Biosimilars, Biobetters & Biosuperiors
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/18/2014)... DUBLIN , Sept. 18, 2014 ... the "Global and Chinese Stem Cell Industry Report, ... Stem cells are undifferentiated biological cells that can differentiate ... produce more stem cells. Stem cell therapy can be ... of hematological system disease), nervous system diseases, damage or ...
(Date:9/18/2014)... , Sept. 18, 2014 Research ... "Global Human Albumin Industry Report 2014" report ... Albumin Industry Report 2014 is a professional and in-depth ... albumin industry. The report provides a basic ... industry chain structure. The human albumin market analysis is ...
(Date:9/18/2014)... Leatherwood Plastics has selected Vycom’s ... stay competitive in the semiconductor, clean room and ... impact product quality and productivity, according to Dwight ... in 1980 in Lewisville, TX, Leatherwood Plastics ... left the business. Much of Leatherwood’s equipment building ...
(Date:9/18/2014)... Pharma, Inc. (Nasdaq: MEIP ), an oncology company ... announced today that Daniel P. Gold , Ph.D., President ... in the Biotech Industry conference on Friday, September 26, ... Hotel & Conference Center in New York ... at www.meipharma.com . A replay will be available approximately ...
Breaking Biology Technology:Global and Chinese Stem Cell Industry Report, 2014-2017 2Global and Chinese Stem Cell Industry Report, 2014-2017 3Global Human Albumin Industry Report 2014 2Global Human Albumin Industry Report 2014 3Leatherwood Plastics Selects Vycom’s Flametec PVC-C Material to Stay Competitive in Semiconductor and Lab Equipment Industries 2MEI Pharma To Present At BioCentury's NewsMakers Conference 2MEI Pharma To Present At BioCentury's NewsMakers Conference 3
... from Betsy McCaughey, Ph.D., the author of the recent ... Plan."I am requesting that MSNBC and Keith Olbermann apologize ... Betsy McCaughey, Ph.D. was paid, directly or indirectly, by ... or Cantel Medical Corp. to write my analysis of ...
... Inc. (Nasdaq: SVNT ) announced today that ... quarter and year-end 2008 following the close of the ... and David Gionco, Vice President and Chief Financial Officer, ... 10:00 a.m. Eastern Time on February 26, 2009 to ...
... Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX ), a biopharmaceutical ... the treatment of human viral and other infectious diseases, today ... ended December 31, 2008. At December 31, 2008, Idenix,s cash, ... , , ...
Cached Biology Technology:Savient Pharmaceuticals to Hold Fourth Quarter and Year-End 2008 Results Conference Call on Thursday, February 26, 2009 2Idenix Pharmaceuticals Reports Fourth Quarter and Year End Financial Results 2Idenix Pharmaceuticals Reports Fourth Quarter and Year End Financial Results 3Idenix Pharmaceuticals Reports Fourth Quarter and Year End Financial Results 4Idenix Pharmaceuticals Reports Fourth Quarter and Year End Financial Results 5Idenix Pharmaceuticals Reports Fourth Quarter and Year End Financial Results 6Idenix Pharmaceuticals Reports Fourth Quarter and Year End Financial Results 7
(Date:9/19/2014)... a species which over thousands of years has adapted to ... substance that makes the cold dangerous for you. , This ... , and the cold provoking substance, called nonylphenol, comes from ... is suspected of being a endocrine disruptor, but when entering ... worm,s ability to protect the cells in its body from ...
(Date:9/19/2014)... plants regulate their symbiotic relationship with soil bacteria ... the plant structure from leaves into the roots ... the roots. This collaborative study was conducted by ... the Graduate University for Advanced Studies (SOKENDAI), and ... Japan. , Legumes, an important plant family ...
(Date:9/18/2014)... A new GSA Bulletin study uses ... Rio Puerco and Chaco Wash in northern New Mexico, ... salt cedar and willow, investigators were able to precisely ... They then combined this data with aerial imagery, LiDAR, ... of these arroyos. , Arroyos are deep, oversized channels ...
Breaking Biology News(10 mins):Environmental pollutants make worms susceptible to cold 2Environmental pollutants make worms susceptible to cold 3For legume plants, a new route from shoot to root 2Tree rings and arroyos 2Tree rings and arroyos 3Tree rings and arroyos 4Tree rings and arroyos 5Tree rings and arroyos 6Tree rings and arroyos 7
... basic questions about how life originated and has ... Foundation,s (NSF) Division of Environmental Biology (DEB). Ranging ... NSF,s awards for these studies will help resolve ... responses to environmental changes, including climate change. ...
... in the United States and United Kingdom are ... more closely on atmospheric science and technology. The ... research collaborations while developing joint educational and training ... years, is between the U.S. National Center for ...
... must devote more resources to research into the ... according to a paper published today in the ... National Research Flagship. ,"Marine ecosystems are undoubtedly under-resourced, ... of impacts on marine life is a mere ...
Cached Biology News:National Science Foundation funds research addressing enduring questions of life 2National Science Foundation funds research addressing enduring questions of life 3National Science Foundation funds research addressing enduring questions of life 4US and UK research centers launch major collaboration on atmospheric research, technology 2Ocean life under threat from climate change 2
... breakthrough in accurate, small-volume bulk dispensing. Dispensing precise ... 1 has unique advantages not found in any ... needs re-calibration as do other 1mL dispensers. ... Display , Graphical Row Selection , 96-,384- and ...
... microscopes offer all of the features of ... Equipped with Koehler illumination, a centerable condenser ... B3 is the workhorse of Motic's range ... the need for re-focusing following a change ...
... The Thermo Sequenase Dye Primer Manual ... used with fluorescent dye-labeled primers and high-resolution ... step followed by standard slab gel electrophoresis ... fluorescently tagged sequencing products. The kit ...
Rabbit polyclonal to Esa1 ( Abpromise for all tested applications)....
Biology Products: