Biologics Naming: WHO Final Plan, FDA Draft Guidance Incompatible
Executive Summary
US regulator could try to harmonize its nonproprietary naming approach with World Health Organization's biological qualifier system or stick with its suffix-based proposal; while having different names across the globe for a single product is not ideal, it's also not an insurmountable problem, experts say.
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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.
Biologics Naming: US FDA Ponders How To Put New System In Place, While WHO Puts Hold On Pilot Study
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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