The Generic Pharmaceutical Association (GPhA) has requested in a citizen petition filed with the U.S. Food and Drug Administration that the agency implement its International Non-proprietary Naming (INN) system policy “equally to all biologics,” including biosimilar drug products. GPhA justified its request by claiming that biopharmaceuticals, “by definition . . . are ‘highly similar’ to the reference biologics and have no clinically meaningful differences that require a unique name.” According to GPhA CEO and President Ralph Neas, “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.”
The association contends that FDA outlined its biosimilars naming policy in a paper submitted to the World Health Organization (WHO) in 2006, in support of current WHO naming conventions. FDA apparently stated at that time that non-proprietary names should be used to communicate interchangeability, rejecting distinctive INN designations for biosimilars. See GPhA Press Release, September 19, 2013.