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Drug Discov Today. 2015 Apr;20(4):393-8. doi: 10.1016/j.drudis.2014.09.003. Epub 2014 Sep 16.

An overview of FDA-approved biologics medicines.

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Washington University in St Louis, St Louis, MO 63110, USA. Electronic address:


Recombinant DNA technologies revolutionized medicine. Herein, the approvals and mechanistic basis of biologics-based medicines are analyzed. The overall and relative rate of FDA approvals for recombinant proteins grew from the 1980s through the first half-decade of the new millennium. Over time, the number of biologics gaining approval for an orphan indication has climbed to more than 50% in the current decade. The field has been dynamic in terms of the types of biologics, indications targeted and the mechanistic basis of drug activity. Despite impressive increases in recombinant-protein-based medicine, the rate of new biologics approvals could have leveled out.

[Indexed for MEDLINE]

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