FDA releases position on naming FOBs

FDA expressed a preference against changing the World Health Organization's international nonproprietary names (INN) system as a means to prevent inappropriate substitution of follow-on biologics (FOBs). Trade organizations including the Pharmaceutical Research and Manufacturers of America (PhRMA), European Biopharmaceutical Enterprises (EBE), and the European Federation of Pharmaceutical Industries and Associations (EFPIA) have proposed that biosimilar products made by different manufacturers be given unique INNs (generic names).

In a paper distributed at a meeting of WHO's INN Expert Group in Geneva, FDA said its position is contingent on the international adoption of policies that do not rely on nomenclature alone for postmarket tracking of products or to prevent inappropriate substitution. The agency said it prefers that INNs "continue to be granted based only on molecular characteristics and pharmacological class of the active ingredient(s)." It added that "this view is predicated on the situation in the U.S., where there are alternative mechanisms in place for preventing potentially dangerous substitutions and ensuring that potentially unsafe drug dispensing decisions are not made because of a misperception that the same INN implies pharmacologic interchangeability." ...