Equivalence of generic medicines in general and immunosuppressants in particular – a regulatory opinion on switching of ciclosporin, tacrolimus and mycophenolate mofetil
Journal Title: Generics and Biosimilars Initiative Journal - Year 2013, Vol 2, Issue 2
Abstract
This position paper deals with our regulatory opinion on registered generic immunosuppressants such as ciclosporin, tacrolimus and mycophenolate mofetil, and provides arguments why these medicines are considered equally safe and effective as the branded drug based on demonstrated bioequivalence. Though regulators acknowledge the worries from the field, we are of the opinion that there are no compelling pharmacological arguments to date against the sensible use of generic immunosuppressants in clinical practice, under the shared and mutual care by prescribers and pharmacists.
Authors and Affiliations
Yang Yu, Hubert GM Leufkens, Marc Maliepaard
Keywords
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- EP ID EP355009
- DOI 10.5639/gabij.2013.0202.019
- Views 105
- Downloads 0
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