Should Biosimilars Have the Same Names as Original Biologics?

In a presentation at the World Health Organization's 57th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland, a compelling argument was made 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, argued the following:

• 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

Read the full policy paper

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