FDA Week - 05/10/2019

AAM, AHIP, FTC: FDA Should Retract Plan For Suffixes In Biologic Naming

By Beth Wang / May 8, 2019 at 5:44 PM
The government and major lobby groups oppose FDA’s biologic naming convention, which says that all new biologics, biosimilars and interchangeable biosimilars must have a nonproprietary name followed by a non-meaningful suffix. While the groups agree all products should share a common nonproprietary name, they argue against the use of suffixes of any kind. They also argue that FDA’s proposal to not apply the naming convention to already-approved products is a major misstep that will cause confusion among patients and health...

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