An overview of FDA-approved biologics medicines

Michael S. Kinch

Research output: Contribution to journalShort surveypeer-review

137 Scopus citations


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.

Original languageEnglish
Pages (from-to)393-398
Number of pages6
JournalDrug Discovery Today
Issue number4
StatePublished - Apr 1 2015


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