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FDA Week - 05/10/2019

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

May 08, 2019
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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