Generic Industry Calls on FDA to Uphold Consistent, Proven International Standard for Biosimilar Naming


WASHINGTON, DC (Sept. 19, 2013) —The Generic Pharmaceutical Association (GPhA) has filed an official Citizen Petition with the Food and Drug Administration (FDA) 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 G. Neas, president and CEO of the Generic Pharmaceutical Association. “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.”

Despite assertions to the contrary, the petition states that unique names will not enhance safety. Biosimilars using the same INN as their reference products have been on the market in Europe since 2006 with a proven safety record, and there have been no issues with traceability or pharmacovigilance. In the United States, pharmaceutical and biologic products are successfully traced using national drug codes (NDCs), batch and lot numbers.

In addition, the Citizen Petition points out that existing INN policy administered by the World Health Organization (WHO) assures practitioners worldwide that the prescribed product has the same active ingredient and clinical effect as the reference product. The GPhA petition holds that the global INN system to keep patients safe, which has been in place for 50 years and used in scores of countries around the world, should not be changed for one subset class of products.

Consistent biosimilar naming aligns with previous FDA recommendations. In 2006, FDA issued a policy paper to the World Health Organization (WHO), supporting the original purpose of the INN, to identify active ingredients, and reject the use of non-proprietary names to communicate interchangeability.

GPhA continues to encourage a dialogue among FDA and other stakeholders to explore the best way to support the existing system for pharmacovigilance and optimize data collection that ensures patient safety.

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GPhA Citizen Petition