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Is the WHO's "biological qualifier" really needed?

This article was originally published in Scrip

Executive Summary

The World Health Organization has launched a public consultation on its compromise proposal for a "biological qualifier" (BQ) that could be assigned to all biological substances with an international non-proprietary name (INN). The BQ, which would identify the manufacturer and manufacturing site of the active substance, would apply to all substances, regardless of whether the branded product was an originator or a biosimilar drug.



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