US generics industry files Citizen Petition on biosimilar naming

The USA’s Generic Pharmaceutical Association (GPhA) has filed an official Citizen Petition with the Food and Drug Administration detailing its position on biosimilar naming. The petition recommends that all biosimilars approved by the agency share the same international non-proprietary name (INN) as the biologic products to which they refer, because by definition they are “highly similar” to the reference biologics and have no clinically meaningful differences that require a unique name.

“It is simple: biosimilars have no clinically meaningful difference from the reference product, so they should have the same name,” said Ralph Neas, president and chief executive of the GPhA, adding: “This approach works in Europe, it has worked in the United States for chemical drugs, and it should be the standard worldwide. To upset the naming system in place risks engendering confusion and would have a major negative impact throughout the global pharmaceutical supply chain, potentially jeopardizing patient access across the globe.”

Unique name will not enhance safety