Biologics Naming: WHO Final Plan, FDA Draft Guidance Incompatible

Via The Pink Sheet
February 8, 2016
By Sue Sutter

US regulators 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. Bert Liang, CEO of Pfenex, shared with The Pink Sheet why the WHO and the FDA’s naming proposals both have concerning elements for biosimilar uptake.

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