US biosimilars group criticizes WHO proposal on naming

As advocates for policies that support patient access to biosimilars, the Biosimilars Council, a division of the US trade group the Generic Pharmaceutical Association (GPhA), has said it is disappointed in the World Health Organization’s final proposal on the Biological Qualifier (BQ), which could be a barrier to competition from these new versions of critical medicines.

Biosimilars Council chairman Bert Liang commented: “The system proposed by the WHO would assign a random code to the International Nonproprietary Name (INN) for biological substances. This proposal from the WHO is similar (although not exact) to the Food and Drug Administration current guidance on the naming of biosimilars, as it is a nonsensical qualifier allowing identification of one biosimilar or biologic from another. The WHO guidelines are optional for adoption by each regulatory body, so it is expected that, rather than adopting the BQ proposed by the WHO, the FDA will continue to review the public comments received in response to its latest issued draft guidance on naming before finalization.”

Dr Liang continued: “Further to the point of naming, there exists no compelling rationale for added identifiers for biosimilar drugs; on the contrary, based on available estimations, this will likely stifle uptake and market growth in the US and other countries. The INN was designed to identify an active compound, rather than create a base for a branded naming system. Both the WHO and FDA naming proposals adding unique qualifiers to the INN of biosimilars defeats this core purpose.”