Insulins as Drugs or Biologics in the USA: What Difference Does it Make and Why Does it Matter?

por George, Kelly, Woollett, Gillian
Publicado 2019

Worldwide experience with biosimilar development

por McCamish, Mark, Woollett, Gillian
Publicado 2011

A ‘Global Reference’ Comparator for Biosimilar Development

por Webster, Christopher J., Woollett, Gillian R.
Publicado 2017

Comment on “The End of Phase 3 Clinical Trials in Biosimilars Development?”

por Webster, Christopher J., Woollett, Gillian R.
Publicado 2018

Comment on “Analysis of Pharmacokinetic and Pharmacodynamic Parameters in EU-Versus US-Licensed Reference Biological Products: Are In Vivo Bridging Studies Justified for Biosimilar...

por Webster, Christopher J., Woollett, Gillian R.
Publicado 2019

An Efficient Development Paradigm for Biosimilars

por Webster, Christopher J., Wong, Anny C., Woollett, Gillian R.
Publicado 2019

Comparability of Biologics: Global Principles, Evidentiary Consistency and Unrealized Reliance

por Webster, Christopher J., George, Kelly L., Woollett, Gillian R.
Publicado 2021

The Role of PD Biomarkers in Biosimilar Development – To Get the Right Answer One Must First Ask the Right Question

por Woollett, Gillian R., Park, Joseph P., Han, Jihyun, Jung, Byoungin
Publicado 2022

Future Evolution of Biosimilar Development by Application of Current Science and Available Evidence: The Developer’s Perspective

por Cohen, Hillel P., Turner, Matthew, McCabe, Dorothy, Woollett, Gillian R.
Publicado 2023

Switching Reference Medicines to Biosimilars: A Systematic Literature Review of Clinical Outcomes

por Cohen, Hillel P., Blauvelt, Andrew, Rifkin, Robert M., Danese, Silvio, Gokhale, Sameer B., Woollett, Gillian
Publicado 2018

Authors’ Reply to Pires et al.: “Switching Reference Medicines to Biosimilars: A Systematic Literature Review of Clinical Outcomes”

por Cohen, Hillel P., Blauvelt, Andrew, Rifkin, Robert M., Danese, Silvio, Gokhale, Sameer B., Woollett, Gillian
Publicado 2018

Interchangeability for Biologics is a Legal Distinction in the USA, Not a Clinical One

por Park, Joseph P., Jung, Byoungin, Park, Hyung Ki, Shin, Donghoon, Jung, Jin Ah, Ghil, Jeehoon, Han, Jihyun, Kim, Kyung Ah, Woollett, Gillian R.
Publicado 2022