Springer-Verlag
Paris
11523
1776-2596
1776-260X
Targeted Oncology
Targ Oncol
Medicine & Public Health
Oncology
Biomedicine general
7
7
4
1
1
Special focus: Biosimilars
9
2012
3
1
2012
3
2012
Springer-Verlag
2012
Mario
Dicato
188
10.1007/s11523-011-0188-3
7
Risk management of biosimilars in oncology: each medicine is a work in progress
Review
43
49
2011
8
1
2011
7
5
2011
8
1
2012
1
25
The Author(s)
2012
Arnold
G.
Vulto
+31-10-7033202
+31-10-7032400
a.vulto@erasmusmc.nl
Stacy
A.
Crow
Hospital Pharmacy
Erasmus University Medical Center
P.O. Box 2040
3000 CA
Rotterdam
The Netherlands
Abstract
Drug licensing and drug safety monitoring for standard chemical entities have been established and are routinely used. These have resulted in a solid foundation of knowledge from which confident therapeutic decisions can be made. For many chemical entities, this advanced level of experience is also present for the generic products. The expertise surrounding the development of biosimilar competitor versions is increasing and progress is encouraging. To address the re-engineering and comparability complexities of biosimilars, the European Union imposed a requirement that risk management plans be included in the medications’ marketing applications. This paper summarizes and discusses the circumstances complicating the public’s view of drug safety, historical incidents during the transition from innovative to competitor products, as well as retrospective assessments of the development and post-marketing experiences thus far with two biosimilars. Through assessing the market entries and post-marketing experiences of biosimilars used in oncology, the healthcare field can better prepare for the next wave of comparator-products: biosimilar monoclonal antibodies.
Keywords
Risk management
Drug licensing
Drug safety
Biosimilar
Monoclonal antibody
Oncology
This article is a revision of Vulto AG (2011) Risk management of biosimilars in oncology. Oncologie 13(5):196–200