BIO Responds to GPhA Citizen Petition on Biosimilars Naming

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 support the need for distinguishable naming of all biologics. We believe it is possible to craft a nonproprietary naming convention that both contributes to patient safety through enhanced product identification and improves access to medicines at competitive prices.

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