USA’s GPhA and numerous other groups lodge concerns on biosimilars names

A total of 32 organizations have signed a letter calling on the US Food and Drug Administration to require biologics and biosimilars to have the same International Nonproprietary Name (INN), a practice currently in use 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 US biosimilars, said Ralph Neas, president and chief executive of the Generic Pharmaceutical Association (GPhA). “The organizations who know the most about health care delivery agree: departing from the currently accepted INN system will not benefit patients,” said Mr Neas, adding: “Instead, it will upset the very systems needed to accurately dispense and track medicines, risking increased mistakes and provider confusion.”

As the letter states, “While we agree that it is important to gather data that allows providers to better understand how biologics and biosimilars are performing among various patient groups and to assist in the tracking of adverse events, as we mention above, we believe that the current mechanisms in place (eg, NDC code, lot number, brand name, manufacturer, etc) are sufficient. In addition, because adverse events and product recalls for small-molecule and biologic drugs already are successfully identified using the national drug code (NDC code) and lot number, there is no compelling evidence that biosimilars should be handled differently.”