Industry, Patient Groups Weigh in on FDA's Biosimilar Naming Guidance

Thursday, October 29, 2015

Source: RAPS

Industry is calling on the US Food and Drug Administration (FDA) to use to use "meaningful" and "distinguishable" suffixes linked to a biosimilar license holder's name, according to comments on the proposed naming system.

In total, FDA received 178 comments on its draft guidance, known as Nonproprietary Naming of Biological Products, including clear calls for changes to FDA's proposal.


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