BIO Calls for Updating WHO's Naming Policy for Biological Products

Washington, DC (Nov. 13)-The Biotechnology Industry Organization (BIO, www.bio.org) is urging the World Health Organization (WHO, Geneva, Switzerland, www.who.int) to assign a distinct international nonproprietary name (INN) to each unique biological product, including follow-on biologics or biosimilars.

Earlier this month, WHO hosted an open meeting in Geneva to collect views from both the innovator and generic drug industries on the INN-naming conventions for biotechnology-derived drugs, including biosimilars. The meeting considered whether biologics produced by different manufacturers should be given the same INN as the innovator product, or a distinct INN to reflect the variations produced by differing biological processes.

INNs identify pharmaceutical substances or active pharmaceutical ingredients. The names that are given the status of an INN are selected by the WHO on the advice of the WHO Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations. Each INN is a unique name that is globally recognized and is public property. INNs serve as the basis for international nomenclature for pharmaceutical substances to facilitate clear identification, safe prescription and dispensing of medicines to patients, and for communication and exchange of information among scientists and health professionals. These nonproprietary or generic names are intended for use in pharmacopoeias, labeling, product information, drug regulation and scientific literature, advertising and other promotional material, and as a basis for product names (1).

“One of our concerns is that current requirements for naming and labeling may lead to inappropriate assumptions about sameness and interchangeability of biological medicines,” said BIO’s President and CEO Jim Greenwood in a prepared statement. “Biological products are different from traditional drugs in their complexity, development, and production processes, and each biological product is unique. Unlike traditional generic drugs, follow-on biologics are not identical to the referenced product.”

Greenwood further elaborated that a distinct INN would greatly facilitate tracing the drug back to the correct manufacturer in the event of an adverse event. “BIO agrees with the FDA's assessment that ‘it is important that patients and physicians be aware that protein products with similar molecular composition may indeed not be interchangeable,’ and believes that assignment of distinct INNs to biological medicines is essential,” he said.

In making its case for distinct INNs for biological products, BIO is joining with other pharmaceutical and biotechnology trade associations: the Pharmaceutical Research and Manufacturers of America (Washington, DC, www.phrma.org), the International Federation of Pharmaceutical Manufacturers (Geneva, www.ifpma.org), the European Biopharmaceutical Enterprises (EBE, Brussels, Belgium, www.ebe-biopharma.org), the European Federation of Pharmaceutical Industries and Associations (EFPIA, Brussels, www.efpia.org), and EuropaBio (Brussels, europabio.org).

In July, the EBE-EFPIA issued a technical position paper on the naming of biosimilar medicinal products (www.ebe-biopharma.org/docs/pdf/Biosims_EBEEFPIAPosition_Naming_7July2006.pdf ). 

1. Guidance on International Nonproprietary Names, World Health Organization (Geneva, Switzerland), http://www.who.int/medicines/services/inn/en/, accessed Nov. 20, 2006.