Petition Requests Consistency in Biosimilar and Reference Biologic Names

The Generic Pharmaceutical Association petition recommends that the FDA use the active ingredient in a reference biologic when naming a biosimilar product.

A Generic Pharmaceutical Association (GPhA) petition filed with the FDA last week requests that biosimilar products have the same name as compounds in the reference biologic.

The practice would not only follow naming conventions for pre- and postmanufacturing reference biologic products and traditional, small-molecule generic drugs, but would prevent confusion and duplicate therapy, the petition states.

The practice would also reflect European biosimilar naming conventions, which have been in place for years.

“It is simple: biosimilars have no clinically meaningful difference from the reference product, so they should have the same name,” Ralph G. Neas, GPhA president and CEO, said in a press release. “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.”

GPhA submitted its petition on September 17, 2013. According to the FDA’s Code of Federal Regulations for the statute referenced by GPhA, the FDA Commissioner is expected to rule on petitions within 180 days of the filing. The commissioner may accept, reject, or provide a tentative response to the petition detailing why the FDA could not provide a final response by its deadline.

The commissioner is expected to consider the FDA’s available resources within the area the petition references; the priority assigned to the petition, which is based on the petition subject and the agency’s current projects within that area; and the time requirements established by the statute under which the petition is submitted.

Although the FDA has yet to release a final guidance on biosimilar approval, the 23-page petition requests that all biosimilar products have the same international nonproprietary name (INN) as the reference biologic. The INN, a naming convention administered by the World Health Organization (WHO), already figures into the selection of traditional generic product names within the United States, as the United States Adopted Name Council, the council responsible for product names, collaborates with the WHO. INNs, whether used for biologics or small-molecule drugs, typically reference the active ingredient in the therapy, GPhA’s petition notes.

“To keep with the intent of the INN, which is to allow immediate identification of a product’s active ingredient, all biosimilar products should share an INN with their RPP [reference protein product] because they must contain, as a fundamental requirement of their licensure, the same active ingredient,” the petition notes.

The petition also recommends that biosimilar product labels include a statement similar to that of generic drugs, which states the reference product’s brand name. Concerns regarding safety, traceability, and pharmacovigilance can be addressed using national drug codes, batch, and lot numbers, the petition notes. That practice is already in use with traditional generic and brand name drugs, as well as brand name biologics.