FDA Urged to Preserve Biosimilar Naming Conventions - Pharmaceutical Technology

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FDA Urged to Preserve Biosimilar Naming Conventions


The Generic Pharmaceutical Association (GPhA) is reporting that 32 organizations, including pharmacies and labor unions, have signed a letter urging FDA to require biologics and biosimilars to have the same International Nonproprietary Name (INN). The practice is already established in Europe and other markets.

“These groups understand that the INN approach to biosimilar naming has proven safe and effective in Europe; it has worked in the United States for chemical drugs and currently approved biologics, therefore it should be the standard for U.S. biosimilars," said Ralph G. Neas, president and CEO of GPhA, in a press release. “The organizations who know the most about healthcare delivery agree: departing from the currently accepted INN system will not benefit patients,” said Neas. “Instead, it will upset the very systems needed to accurately dispense and track medicines, risking increased mistakes and provider confusion.”

The letter follows concerns raised by the National Council of Prescription Drug Programs (NCPDP). In a letter to FDA, NCPDP cited operational problems with the implementation of a system other than the current INN system and stated concerns about what kind of impact that a change in system would have on standard operating procedures.

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