Biological Qualifier

Following requests from some drug regulatory authorities, the INN Expert Group recommended that WHO develop a system for assignment of Biological Qualifiers to similar biotherapeutic products (SBPs).

After discussions among interested parties and approval by the INN Expert Group, a voluntary scheme is proposed by which an application can be made to the INN Secretariat for a Biological Qualifier (BQ).

A BQ is an alphabetic code assigned at random to a biological active substance manufactured at a specified site. The scheme is applicable to all biological active substances to which INNs are assigned and is applicable retrospectively.

The BQ code will not be part of the INN, whose selection by the usual procedure will remain unchanged. Where use of a BQ is considered by an authority to be desirable, availability of a single global scheme will avoid proliferation of separate and distinct national qualifier systems. The scheme will be overseen by the WHO INN Expert Group and administered by the WHO INN Secretariat.