Biosimilarity of anticancer monoclonal antibodies in the clinic
Journal Title: Generics and Biosimilars Initiative Journal - Year 2014, Vol 3, Issue 1
Abstract
The European Medicines Agency recommends the use of pharmacodynamics (PD) markers when establishing biosimilarity, but no such biomarkers are known for the clinical efficacy of bevacizumab (Avastin). For this reason, confirmatory clinical efficacy studies are essential, write Hans Ebbers et al. of Utrecht University in The Netherlands [1].
Authors and Affiliations
GaBI Journal Editor
Keywords
Related Articles
- EP ID EP354247
- DOI 10.5639/gabij.2014.0301.013
- Views 141
- Downloads 0
Biosimilarity in Latin America
The introduction of new legislation in Latin America for the approval of biosimilar products follows implementation of EU legislation in 2005 for biosimilars approval. The establishment of regulatory processes for these...
What to look forward to in GaBI Journal, 2012, issue 2
It is my pleasure to introduce the second edition of GaBI Journalwhich contains a number of interesting articles. Professors Benjamin and Kearns present a review of advances in paediatric drug development and labelling,...
Tighter EU rules on pharmacovigilance for biologicals
The new EU pharmacovigilance legislation which comes into force in July 2012 will include a tightening of requirements relating to product information and identification, as well as the regulations surrounding biosimilar...
Alleviating concerns around generic antiepileptic medications
Epilepsy features the unpredictable onset of seizures that can be devastating to a patient’s quality of life. Fortunately there are medications available to control the onset of seizures. But because these have to be tak...
A review of generic medicine pricing in Europe
Introduction: Switching from originator products to generic equivalents is a key method used by governments to reduce costs and keep their healthcare systems sustainable. The aim of this article is to review generic medi...