Federal agencies urged to require same names for biosimilars

In a letter sent Tuesday to the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA), the Biosimilars Council joined a group of health care stakeholders arguing adopting distinguishable names for biosimilars and biologics would create hurdles for patient's access to new, more affordable medicines.

"Organizations representing the nation's pharmacies, pharmacists, insurers, state employee retirement systems, taxpayers and others agree that biologics and biosimilars should share the same name in order to ensure patient safety and avoid confusion among providers and dispensers," Biosimilars Council President and CEO Ralph Neas said.

The groups believe that the current mechanisms in place for naming are more than sufficient to allow for the tracking of important safety information related to new biosimilar products. They urge HHS and FDA to avoid any departure from the currently accepted international nonproprietary naming (INN) system.

“Requiring different INNs for biologics and biosimilars could lead to patient and prescriber confusion, increasing the possibility of medication errors, and would also effectively separate the biosimilar from existing safety information about the underlying molecule," the letter said. "We are concerned that any unnecessary changes may interfere with current pharmacy safety alert systems used by both retail and community pharmacists. In addition, because adverse events and product recalls for small-molecule and biologic drugs already are successfully identified using the national drug code and lot number, there is no compelling evidence that biosimilars should be handled differently."

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