Biosimilar monoclonal antibodies – time for a regulatory rethink
Journal Title: Generics and Biosimilars Initiative Journal - Year 2013, Vol 2, Issue 3
Abstract
The approval of biosimilars in the European Union (EU) is governed by the EU biosimilar framework released in 2004. But new arrivals on the biosimilar stage – monoclonal antibodies – are forcing regulatory authorities to reconsider what constitutes a biosimilar, writes Dr Ebbers and co-authors [1].
Authors and Affiliations
GaBI Journal Editor
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- EP ID EP354912
- DOI 10.5639/gabij.2013.0203.041
- Views 138
- Downloads 0
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