What’s in a Name? WHO Unveils Final Biological Naming Convention That Differs from FDA's

The World Health Organization (WHO) has come out with a final biosimilars naming policy that differs from the U.S. FDA's proposal to attach a suffix to the nonproprietary name of a product. WHO's plan urges international regulators to assign all biological substances a code of four random consonants, which would be independent from the International Nonproprietary Name. The U.S. organization PhRMA supports globally harmonized suffixes to the extent feasible without delaying implementation of the suffix convention in the U.S. HealthPolicyWeek. My company Precision Health Economics has been heavily involved in the analysis of differential biological naming and its effects on patient safety. When unsafe products cannot be traced back quickly to their manufacturer due to naming, manufacturers have a lower incentive to ensure that their products are safe. See my Forbes op-ed for a more detailed discussion on biological naming.