Improving oncology biosimilar launches in the EU, the USA, and Japan: an updated Policy Review from the Southern Network on Adverse Reactions

Author:

Bennett Charles L,Schoen Martin W,Hoque Shamia,Witherspoon Bartlett J,Aboulafia David M,Hwang Catherine S,Ray Paul,Yarnold Paul R,Chen Brian K,Schooley Benjamin,Taylor Matthew A,Wyatt Michael D,Hrushesky William J,Yang Y Tony

Publisher

Elsevier BV

Subject

Oncology

Reference40 articles.

1. Regulatory and clinical considerations for biosimilar oncology drugs;Bennett;Lancet Oncol,2014

2. Postmarket policy considerations for biosimilar oncology drugs;Renwick;Lancet Oncol,2016

3. Biosimilars: the US regulatory framework;Christl;Annu Rev Med,2017

4. Biosimilars in oncology in the United States: a review;Nabhan;JAMA Oncol,2018

5. Systematic approach to pharmacovigilance beyond the limits: the Southern Network on Adverse Reactions (SONAR) projects;Lu;Adv Pharmacoepidemiol Drug Saf,2014

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