IGBA and GPhA Oppose WHO’s Biological Qualifier Approach

Regulatory Guidances

As we have previously reported, the WHO is considering a proposal to assign Biological Qualifiers (BQs), which are alphabetic codes assigned at random, to help standardize naming of biologics. But not everyone is on board with the WHO’s proposal.

The International Generic and Biosimilar medicines Association (IGBA) has recently called for an impact assessment with regard to the BQ proposal. Because the final report is on a short timeline, IGBA is concerned that the WHO will not have time for a full assessment of the impact of the proposal on international stakeholders and areas affected by the BQ proposal. IGBA is concerned that the proposal of a random alphanumeric code nomenclature is “meaningless, unmemorable, confusing, [and] unnecessarily complicated”. IGBA is also concerned that retroactive application of the BQ system to already licensed products could lead to an anticompetitive situation between existing reference biologics. Finally, IGBA has concerns about transparency regarding the national drug authorities who requested development of a global identification system.

IGBA therefore called upon the WHO to push off the timeline for the final BQ report by six months, and to increase transparency regarding positions on the BQ during consultation periods, particularly those of national drug authorities requesting action by the WHO.

On March 2, the Generic Pharmaceutical Association (GPhA) also joined IGBA’s call for an impact assessment, sharing IGBA’s concern that the WHO would need more time to properly evaluate the impact that the BQ proposal would have on systems already in place.

We will continue to monitor this, and other biosimilar stories, as they develop.

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