BIO Suggests Update to WHO’s Naming Policy for Biological Products

WASHINGTON, D.C. (November 13, 2006) -- Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood today issued the following statement regarding the World Health Organization’s program on the selection of International Nonproprietary Names (INN):

“Today, BIO presented its recommendations to the World Health Organization (WHO) to assign a distinct nonproprietary name to each unique biological product, including follow-on biologics (“biosimilars”). We are associated with five other trade associations presenting one voice to the WHO International Nonproprietary Names (INN) Programme. Along with European Biopharmaceutical Enterprises, the European Federation of Pharmaceutical Industries and Associations, EuropaBio, the International Federation of Pharmaceutical Manufacturers and the Pharmaceutical Research and Manufacturers of America, we acknowledge the WHO’s efforts to consider updating international naming conventions to account for the complexity of biological products.

“A policy of assigning distinct names to biological products will best satisfy the objectives of the WHO’s Guidance on INN: ‘the clear identification, safe prescription and dispensing of medicines to patients, and communication and exchange of information among health professionals and scientists worldwide.’

“One of our concerns is that current requirements for naming and labeling may lead to inappropriate assumptions about sameness and interchangeability of biological medicines. 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 reference product. In fact, the European Medicines Agency has stated that ‘due to the complexity of biological/biotechnology-derived products the generic approach is scientifically not appropriate for these products.’

“Unlike traditional generic drugs, follow-on biologics are also not interchangeable with the reference product. Patients could respond very differently to the innovative product and any biosimilar versions. Inadvertent substitution of one version of a medicine for another could have negative clinical consequences. If an adverse event occurs with a biological medicine, it is critical that it be traced promptly to the correct manufacturer. This tracing would be greatly facilitated if all biological medicines had a distinct INN. Because physicians may use the INN in prescribing and as an indicator of interchangeability, 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.

“We strongly urge the WHO to act to provide each unique biological product a distinct name.”