Federal Register (08/28/15)

The Food and Drug Administration (FDA) has released draft guidance regarding the need for biological products licensed under the Public Health Service (PHS) Act to have a nonproprietary name with an FDA-designated suffix. In the "Nonproprietary Naming of Biological Products" guidance, FDA states: "Our current thinking is that shared nonproprietary names are not appropriate for all biological products." The agency says that biological products should be clearly identified to improve pharmacovigilance and differentiate among biological products that are not considered interchangeable. FDA intends to designate a nonproprietary name with a four-letter, lowercase suffix for biological products licensed under the PHS Act. A unique suffix will be included in nonproprietary names of originator biological products, related biological products, and biosimilars. FDA has not yet decided whether the nonproprietary name for an interchangeable product should have a unique suffix, or the same suffix as the reference product. Comments on the draft guidance, as well as suggestions for how to improve active pharmacovigilance systems for monitoring biological products, are being accepted through Oct. 27, 2015.

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