US GENERIC INDUSTRY OPPOSES CHANGES FOR BIOMEDS

Representatives of the USgeneric drug industry have voicedconcerns over foreign proposalsto tinker with the World HealthOrganization's (WHO) process forassigning "International NonproprietaryNames" (INN) to pharmaceuticals.The INN program wasestablished some 50 years ago toassign internationally recognizedgeneric names to pharmaceuticalsubstances so that each could beidentified globally by a uniquename.

The expected upsurge in thedevelopment of generic biomedicines,however, has prompted proposalsfor changes in the INNnaming system that officials at theGeneric Pharmaceutical Association(GPhA) believe could createconfusion and public health concerns.During a meeting withinternational health officials inGeneva, GPhA regulatory affairsvice president Gordon Johnston,RPh, expressed doubts aboutassigning different INN numbersbased on decisions by WHO concerningthe "comparability" ofbiomedicines.

"Multiple biologics have receivedthe same INNs, and therehave been no safety problemsshown to result from these productsbeing confused," he told theUnited Nations' health organization."Scientific determinationsof comparability should be conductedby national regulatoryauthorities."

From the US perspective, thesupposed problem with the currentINN system is a "hypotheticalissue raised by special interests," the GPhA spokesman said."Different INNs for the sameingredient will likely lead to moreconfusion, not less."

Stressing that GPhA agrees withthe "FDA position that changes tothe INN program are unwarrantedand could jeopardize public healthbenefits," Johnston told WHO."National regulatory authoritiesare in the best position to determineinterchangeability of brandand generic biopharmaceuticals.GPhA continues to support theoriginal purpose of INN and itsimplementation for generic biopharmaceuticals," he said.