FDA Withdraws Document Calling on Biosimilar Developers to Submit 10 Random Suffixes

Regulatory NewsRegulatory News | 21 June 2016 |  By 

The US Food and Drug Administration (FDA) on Tuesday withdrew a document submitted to the Office of Management and Budget (OMB) that offered new details on how biosimilar developers would submit an ordered list of 10 random suffixes as part of the naming process for biologics and biosimilars.

The document, first published 1 June, suggested a shift in FDA’s proposal on biologic and biosimilar naming as it altered the number of random suffixes proposed by developers (from three to 10) and also asked the companies to list them in their order of preference, which called into question the randomness of the suffixes.

FDA spokesman Kristofer Baumgartner told Focus: “The publication of the notice was an administrative error. FDA continues to review comments and work on a final guidance.”

Dr. Leah Christl, FDA’s biosimilar lead, responded to a question on the document submitted to OMB yesterday at a panel discussion on biosimilars and added that 10 was an arbitrary number the agency chose and not an indicator of a reversal toward the use of meaningful suffixes.

The document that is now withdrawn also responded to some of the comments made on the draft biosimilar naming guidance, noting, “Many comments suggested that a meaningful, distinguishable suffix may help to improve pharmacovigilance, enhance safety, and facilitate identification between biological products. Some comments supported use of a random suffix to avoid creating an unfair advantage for specific manufacturers.”

In August 2015, that draft guidance proposed a naming convention to distinguish biological products through the use of a randomly assigned unique four-letter suffix following the product's nonproprietary name.

The agency offered an example of where a reference biologic could be assigned a suffix such as "replicamab-cznm," while a related biosimilar could be named "replicamab-hixf."

Other comments on the draft guidance, according to the document submitted to OMB, suggested a higher burden related to coming up with the proposed non-proprietary names so FDA revised its “estimate upward to account for burden associated with creating and submitting up to 10 proposed suffixes for designation.”

Withdrawal of Notice




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