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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Suffix Smackdown: Gottlieb Calls Issue 'Red Herring' For Biosimilars
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WHO Still Planning Biosimilar Naming Guidance, Gives Update On Prequalification Pilot
Despite putting it on hold last year, the World Health Organization is keeping its idea of biosimilar naming guidance alive. And at a recent conference it updated delegates on the pilot project for prequalifying biosimilar versions of infliximab and trastuzumab.