Biologics Naming: US FDA Ponders How To Put New System In Place, While WHO Puts Hold On Pilot Study
Executive Summary
US regulator is currently focused on prospective application of suffix-based naming system for most novel biologics and biosimilars but is still considering how best to change the names of existing products. Meanwhile, World Health Organizations announces it will not proceed 'at present' with its biological qualifier program.
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Pending Biosimilars
Biosimilar applications using the 351(k) pathway under review at US FDA. Updated upon new submissions.