Tag Archives: International Nonproprietary Name

BIO Responds to GPhA Citizen Petition on Biosimilars Naming

FDA115x76

Last September, the Generic Pharmaceutical Association (GPhA) filed a Citizen Petition with the FDA, requesting the FDA to “implement its INN naming policy equally to all biologics” and to require “all biologics approved under the Section 351(k) pathway…share the same INN [International Nonproprietary Name] as the RPP [reference protein product]” (the GPhA Petition). Today, BIO submitted our response. Contrary to the GPhA Petition, BIO believes that the legal, regulatory, and scientific principles related to biologics and biosimilarity Read More >

Health  |  Leave a comment  |  Email This Post
Tags: , , , , , , , , ,