Current Pharmaceutical Biotechnology

Zeno Foldes-Papp
Visiting Professor of Medical Biochemistry
HELIOS Clinical Center of Emergency Medicine
Department for Internal Medicine
Alte-Koelner-Strasse 9
D-51688 Koeln-Wipperfuerth
Germany

Back

Monoclonal Antibodies as Innovative Therapeutics

Author(s): Janice M. Reichert

Affiliation: Tufts University, Tufts Center for the Study of Drug Development, 75 Kneeland Street, Suite 1100, Boston, MA 02111 USA.

Abstract:

Monoclonal antibodies (mAbs) comprise the majority of protein candidates currently in clinical development because of their versatility as therapeutic agents. While traditionally associated with the biotechnology industry, mAb therapeutics are now being developed and marketed by most major pharmaceutical firms. A total of 21 products are approved in the US, with additional products marketed outside the US, and over 200 mAb candidates are currently undergoing clinical study. Benchmark data for mAb therapeutics, such as clinical development and US Food and Drug Administration approval times, approval success rates, and clinical phase transition probabilities, are critical for strategic planning purposes. Trends in these benchmarks for various types of mAbs, with an emphasis on those studied as anticancer and immunological therapeutics, are discussed.

Keywords: Monoclonal antibodies, success rates, clinical study, Food and Drug Administration, marketing approval, benchmarks

Order Reprints Order Eprints Rights & PermissionsPrintExport

Article Details

VOLUME: 9
ISSUE: 6
Page: [423 - 430]
Pages: 8
DOI: 10.2174/138920108786786358