Biosimilars Policy

PUBLICATION  TITLE AUTHOR DATE
BioDrugs “Pharmacovigilance Considerations for Biosimilars in the USA”
Thomas Felix
Gustavo Grampp
September 29, 2015
BioDrugs “Similar Names for Similar Biologics”
Nicole Casadevall
Thomas Felix
Bruce E. Strober
David G. Warnock
July 8, 2014
Nature Biotechnology “Biologic product identification and US pharmacovigilance in the biosimilars era”
Thomas Felix
Torbjorn T. Johansson
Jodi A Colliatie
Michael R Goldberg
Andrew R Fox
February 2014

 Complexity of Biologics Manufacturing

PUBLICATION  TITLE AUTHOR DATE
BioDrugs “Drift, Evolution, and Divergence in Biologics and Biosimilars Manufacturing”
Sundar Ramanan
Gustavo Grampp
February 25, 2014
Generics and Biosimilars Initiative Journal “Steps to ensure adequate supply of biological medicines: considerations for the healthcare provider”
Andrew Mica
Martha Mutomba
Larry Green

June 7, 2013
BioDrugs “Managing Unexpected Events in the Manufacturing of Biologic Medicines”
Gustavo Grampp
Sundar Ramanan
March 26, 2013
Current Medical Research & Opinion
“Comparability and biosimilarity: considerations for the healthcare provider”
Jaymi Lee
Jason Litten
Gustavo Grampp
May 31, 2012

 Physician Considerations

PUBLICATION  TITLE AUTHOR DATE
Cancer Medicine “Biosimilars 101: considerations for U.S. oncologists in clinical practice.”
LH Camacho
CP Frost
E Abella
PK Morrow
S. Whittaker
August 2014