Navigation Links
Biosimilars Need Same Names as Original Biologics, Hospira Says at World Health Organization (WHO) Meeting

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 policy paper on biosimilars naming, in which he draws on his own experience as a physician prescribing medications.

Biosimilars are biologic medicines proven to have similar clinical effects as biologics, but at a more affordable cost to both the healthcare system and patients. In Europe, biosimilars have helped lower costs by 20 percent to 30 percent[i]. It's estimated that biosimilars could save the U.S. healthcare system $20 billion annually[ii]. The U.S. biosimilars market is expected to develop around mid-decade[i].

Learn more about how biosimilars will impact healthcare at

Hospira is the first U.S. company to sell biosimilars in Europe, launching its erythropoietin product, Retacrit™ in early 2008. It also sells Nivestim™, a filgrastim biosimilar, in Europe and Australia, and in 2013 received European approval for Inflectra™, its biosimilar version of infliximab. Hospira is currently conducting a Phase III U.S. clinical trial program for its U.S. epoetin product, which is being developed as a biosimilar to erythropoietin alfa.

About Hospira
Hospira, Inc. is the world's leading provider of injectable drugs and infusion technologies. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill., and has approximately 16,000 employees. Learn more at

[i] IMS Intelligence Incorporated. Shaping the biosimilars opportunity: A global perspective on the evolving biosimilars landscape. 2011 December. Section 1, Page 2.

[ii] "New Grant Thornton Study Show Immediate Need for Biosimilar Competition." Generic Pharmaceutical Association. 1 February, 2013.

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

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:
(Date:12/1/2015)... Harry Lander , President of Regen, expands his role to ... recruits five distinguished scientists to join advisory team ... expands his role to include serving as ... to join advisory team --> Dr. Harry Lander ... serving as Chief Science Officer and recruits ...
(Date:12/1/2015)... ... 01, 2015 , ... Matthew “Tex” VerMilyea, PhD, HCLD, has joined Texas Fertility ... all IVF lab procedures as well as continue his research efforts into the emerging ... to Auckland, New Zealand to bring home a High Complexity Clinical Laboratory Director named ...
(Date:11/30/2015)... ... 30, 2015 , ... Global Stem Cells Group ... from Central America and abroad for the first Iberoamerican Convention on Aesthetic Medicine, ... 2016. Testart will present and discuss new trends in anti-aging stem cell treatments, ...
(Date:11/30/2015)... ... November 30, 2015 , ... ... Good Manufacturing Practice (GMP) 10000 in the Santiago Marriott. The Global Stem Cells ... operated by a world-class team of qualified medical researchers and practitioners, experienced in ...
Breaking Biology Technology:
(Date:11/17/2015)... Mass. , Nov. 17, 2015 Pressure ... leader in the development and sale of broadly enabling, ... worldwide life sciences industry, today announced it has received ... its $5 million Private Placement (the "Offering"), increasing the ... $4,025,000.  One or more additional closings are expected in ...
(Date:11/12/2015)... 2015  A golden retriever that stayed healthy despite ... has provided a new lead for treating this muscle-wasting ... Institute of MIT and Harvard and the University of ... Cell, pinpoints a protective gene that ... effects. The Boston Children,s lab of Lou Kunkel ...
(Date:11/12/2015)...   Growing need for low-cost, easy to ... paving the way for use of biochemical sensors ... in clinical, agricultural, environmental, food and defense applications. ... medical applications, however, their adoption is increasing in ... emphasis on improving product quality and growing need ...
Breaking Biology News(10 mins):