Advancing Biosimilar Development Using Pharmacodynamic Biomarkers in Clinical Pharmacology Studies

Clin Pharmacol Ther. 2020 Jan;107(1):40-42. doi: 10.1002/cpt.1653. Epub 2019 Oct 31.

Authors

Junyi Li¹, Jeffry Florian¹, Elizabeth Campbell¹, Sarah J Schrieber², Jane P F Bai¹, James L Weaver¹, Paula L Hyland¹, Theingi M Thway¹, Murali K Matta¹, Rachana H Lankapalli¹, Suresh Narayanasamy¹, Jimena Dancy¹, Robbert Zusterzeel¹, Jessica Y Tyson³, Kristin W Prentice³, Kathryn C Jackson³, Vikram Patel¹, Rodney L Rouse¹, Yow-Ming C Wang¹, David G Strauss¹

Affiliations

¹ Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
² Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
³ Booz Allen Hamilton, Mclean, Virginia, USA.

No abstract available

Publication types

Research Support, U.S. Gov't, P.H.S.

MeSH terms

Biomarkers, Pharmacological* / analysis
Biosimilar Pharmaceuticals / pharmacokinetics
Biosimilar Pharmaceuticals / pharmacology*
Drug Approval*
Humans
Pilot Projects
United States
United States Food and Drug Administration

Substances

Biomarkers, Pharmacological
Biosimilar Pharmaceuticals