Access barrier created by distinguishable names for biosimilars, GPhA says

WASHINGTON — The Biosimilars Council, a division of the Generic Pharmaceutical Association, on Tuesday strongly urged the Department of Health and Human Services and the Food and Drug Administration to avoid any departure from the currently accepted international nonproprietary naming system. In a letter sent today to HHS and FDA, the Biosimilars Council joined a group of healthcare stakeholders to raise shared concerns that adopting distinguishable names for biosimilars and biologics would erect barriers to patient access to new, more affordable medicines and could jeopardize their safety.

 

“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,” stated Ralph Neas, president and CEO, GPhA.

 

“We share the FDA's deep commitment to patient safety, and as such, we believe that biologics and biosimilars should be required to have the same International Nonproprietary Name," the Council submitted in its letter. "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 Council suggested that the current mechanisms in place (e.g., NDC code, lot number, brand name, manufacturer, etc.) are more than sufficient to allow for the tracking of important safety information related to new biosimilar products.