The biological qualifier proposal from the WHO would add a unique four letter code to a biological active substance manufactured at a specific site. Separate from the INN (International Nonproprietary Name), the BQ code would aim to complement an INN by identifying both the manufacturer and manufacturing site of the active substance.
“Because of their structural complexity, the complexity of their manufacturing processes using living organisms, the greater difficulties in achieving consistency of manufactured batches and the often complex long-term effects of their administration to a patient, bioequivalence cannot be easily established for a product containing a biological substance,” the WHO says in its July proposal.
USP says in its comment on the BQ proposal that it’s “very supportive” of the plan “and in particular the principle that the BQ should apply to all biologics” as it considers finding “a broadly agreed upon solution that is built on and consistent with existing, accepted scientific principles critical to supporting a globally relevant approach to the quality assessment of biologicals.”
USP “considers it essential that the BQ is not part of the nonproprietary name itself, meaning that the BQ would also not be considered part of any applicable compendial name.
“This will allow consistency with currently applied approaches and not disturb existing precedent where multiple non-interchangeable biologics share the same compendial name and monograph specifications, for example Glucagon and Somatropin,” USP says.
The group also says that the BQ should not be a part of the INN “in order to assure consistency with currently applied compendial approaches.”
While USP has expert representation in both INN and USAN (United States Adopted Names Council) deliberations when drugs are given their names very early in their development, USP’s official role in naming “usually does not come into play until much later in the lifecycle of a licensed drug, when a monograph is developed,” the pharmacopeia says.