US GENERIC INDUSTRY OPPOSES CHANGES FOR BIOMEDS

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Representatives of the US generic drug industry have voiced concerns over foreign proposals to tinker with the World Health Organization's (WHO) process for assigning "International Nonproprietary Names" (INN) to pharmaceuticals. The INN program was established some 50 years ago to assign internationally recognized generic names to pharmaceutical substances so that each could be identified globally by a unique name.

The expected upsurge in the development of generic biomedicines, however, has prompted proposals for changes in the INN naming system that officials at the Generic Pharmaceutical Association (GPhA) believe could create confusion and public health concerns. During a meeting with international health officials in Geneva, GPhA regulatory affairs vice president Gordon Johnston, RPh, expressed doubts about assigning different INN numbers based on decisions by WHO concerning the "comparability" of biomedicines.

"Multiple biologics have received the same INNs, and there have been no safety problems shown to result from these products being confused," he told the United Nations' health organization. "Scientific determinations of comparability should be conducted by national regulatory authorities."

From the US perspective, the supposed problem with the current INN system is a "hypothetical issue raised by special interests," the GPhA spokesman said. "Different INNs for the same ingredient will likely lead to more confusion, not less."

Stressing that GPhA agrees with the "FDA position that changes to the INN program are unwarranted and could jeopardize public health benefits," Johnston told WHO. "National regulatory authorities are in the best position to determine interchangeability of brand and generic biopharmaceuticals. GPhA continues to support the original purpose of INN and its implementation for generic biopharmaceuticals," he said.