USP Supports WHO Biologics Naming Proposal

The United States Pharmacopeial Convention (USP) is backing the assignment of biological qualifiers (BQ) to biotherapeutics. USP has stated that it supports the efforts of the Expert Group of the Programme of International Nonproprietary Names (INN), which plans to develop a consensus-based global approach to the naming of all biologicals. USP stated, in a press release, that the organization agrees with the concept of a BQ that would apply to all biologics and that the BQ should not be part of the nonproprietary name itself in order to assure consistency with currently applied approaches.

In comments to the World Health Organization regarding the INN proposal, USP shared its role in drug naming and its legal basis; the compendial identity of an article published in a USP monograph and its distinction from the regulatory identity of an article; USP’s involvement in INN and the US Adopted Names Council (USAN); and the process and principles behind USP’s naming responsibilities.