FDA Explains Why Newly Approved Biologic’s Name Lacks a Suffix

Posted 17 February 2017 | By Zachary Brennan 

FDA Explains Why Newly Approved Biologic’s Name Lacks a Suffix

The US Food and Drug Administration (FDA) approved a new biologic this week, but its name did not adhere to recently finalized guidance calling for all new and previously approved biologics and biosimilars to have a four-letter random suffix attached to their nonproprietary names.

“This week’s biologic, [Valeant Pharmaceuticals’] Siliq (brodalumab) was licensed under section 351(a) of the Public Health Service Act, and thus is within the scope of our recently issued guidance on the Nonproprietary Naming of Biological Products,” an agency spokesperson told Focus.

“However, FDA issued the final guidance [on 12 January] at a point in our review of the application that did not allow sufficient time for FDA to designate a proper name that includes a suffix as described in the guidance. In order to avoid delaying the approval of brodalumab and in the interest of public health, FDA licensed the biological product with a designated proper name that did not include a suffix. We intend to work with the application holder for this biological product to implement the naming convention described in the guidance.”

That comment follows criticisms from AbbVie, Novartis and others sent to FDA earlier in February. An agency spokesperson told Focus that FDA “intends to continue working with stakeholders to facilitate implementation” of the final guidance.

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