An overview of FDA-approved biologics medicines
MS Kinch - Drug discovery today, 2015 - Elsevier
Drug discovery today, 2015•Elsevier
Highlights•Biologics approvals grew from the early 1980s through 2010, stabilizing
thereafter.•Three different disease categories capture more than 70% of initial antibody
approvals.•The relative number of biologics (to small molecules) might be declining.
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 …
thereafter.•Three different disease categories capture more than 70% of initial antibody
approvals.•The relative number of biologics (to small molecules) might be declining.
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 …
Highlights
- Biologics approvals grew from the early 1980s through 2010, stabilizing thereafter.
- Three different disease categories capture more than 70% of initial antibody approvals.
- The relative number of biologics (to small molecules) might be declining.
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.
Elsevier
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