At the World Health Organization (WHO) in Geneva, Switzerland, Hospira, Inc. said that it is essential for biosimilar drugs to be given the same nonproprietary names as original biologics.
Hospira, the world’s leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars, said that biosimilars should be given the same nonproprietary names as original biologics to ensure that patients receive the full benefit of greater access and lower costs that biosimilars can bring.
Hospira’s global vice president for regulatory affairs, Lisa Skeens, PhD, spoke at the WHO’s 60th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva. She outlined several reasons for biosimilar drugs to be given the same nonproprietary names as original biologics. She referenced Europe’s success with approving biosimilars with the same nonproprietary names as their reference biologics. Europe approved the first biosimilar more than six years ago, and their naming system has proved effective.
Biosimilars have been successfully tracked using their brand name and other identifiers currently in place for product recognition, meaning a separate nonproprietary name is not needed for tracking purposes once the biosimilars are on the market. She said that if the US Food and Drug Administration (FDA) does not follow Europe’s naming process, the full promise of the agency’s decision to approve the first biosimilar in the US will not be realized if patients and healthcare providers are confused by unnecessary variations in nonproprietary names. Additionally, she said that different nonproprietary names for a biologic and the biosimilar patterned on that biologic could cause confusion among clinicians who rely on international and local standards to fill prescriptions, potentially resulting in issues surrounding patient safety and medication access.
Biosimilars are biologic medicines produced at a more affordable cost to both healthcare system and patients. It is estimated that biosimilars could save $20 billion annually for the US healthcare system. In Europe, biosimilars have helped lower costs by 20 to 30 percent.
Source: Hospira, Inc.
Last updated: 4/13/15; 12:05pm EST