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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.
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