FDA Proposes Making Only New Biologic Products Add Suffixes To Name

In a win for brand-biologic drug makers, FDA has reversed course on its 2017 decision to require that all biologics follow a nonproprietary naming protocol. The agency on Thursday (March 7) issued draft guidance that proposes to apply the naming convention only to new originator biologics and interchangeable biosimilars and to exempt currently licensed or approved biologics or products that are in the process of being licensed, including insulin. The agency cited brand-biologic industry concerns that changing the names of...