From: Regulatory Affairs Professional Society
FDA Withdraws Document Calling on Biosimilar Developers to Submit 10 Random Suffixes
By Zachary Brennan
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.
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Other comments on the draft guidance, according to the document submitted to OMB, suggested a higher burden related to coming up with the proposed non-proprietary names so FDA revised its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.”