Biosimilars Need Same Names as Original Biologics, Hospira Says at World Health Organization (WHO) Meeting
-- Proper naming of biosimilars key for patient access, safety --
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 www.hospira.com/biologics.
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.
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 www.hospira.com.
[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. http://www.gphaonline.org/gpha-media/press/gpha-press-granthornton
SOURCE Hospira, Inc.
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