USP Comments to WHO Regarding Biologics Qualifier Proposal


CONTACT:  Theresa Laranang-Mutlu

Rockville, Md., September 23, 2014—The U.S. Pharmacopeial Convention (USP) has submitted comments to a proposal by the World Health Organization (WHO) regarding the assignment of Biological Qualifiers (BQ) to biotherapeutics.

USP supports the effort by the Expert Group of the Programme of International Nonproprietary Names (INN) to develop a consensus-based global approach to the naming of all biologicals that is consistent with existing, accepted scientific principles critical to the quality assessment of these drugs.

Hence, USP supports the concept of a BQ that would apply to all biologics, and agrees that the BQ should not be part of the nonproprietary name itself in order to assure consistency with currently applied approaches.

The WHO proposed the INN BQ approach in July of this year, following requests from some drug regulatory authorities. According to the WHO proposal, “A BQ is an alphabetic code assigned at random to a biological active substance manufactured at a specific site. The INN BQ scheme is applicable to biological active substances to which INNs are assigned and are 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 disparate and distinct national qualifier systems.”

In support of its comment to the INN proposal and to provide broader context to its position, USP elaborates on the following in its submission to WHO:

  • USP’s 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 U.S. Adopted Names Council (USAN)
  • the process and principles behind USP’s naming responsibilities

USP’s public comment to the INN BQ proposal is available at USP’s Web site. To read the INN BQ proposal, click here.