Lenalidomide product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of lenalidomide.

Keywords: Bioequivalence, generics, lenalidomide

Abbreviations:

• BCS Classification: Biopharmaceutics Classification System
• AUC_0-t: area under the plasma concentration curve from administration to last observed concentration at time t
• AUC_0-72: area under the plasma concentration curve from administration to last observed concentration at 72 hours
• C_max: maximum plasma concentration

Current effective version

Lenalidomide hard gelatine capsules 2.5, 5, 7.5, 10, 15 and 25mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/177335/2016 Legal effective date: 01/11/2016 Summary:

This document provides product-specific guidance on demonstration of bioequivalence of lenalidomide

Document history

Overview of comments on 'lenalidomide hard gelatine capsules 2.5, 5, 7.5, 10, 15 and 25mg product-specific bioequivalence guidance’

Reference Number: EMA/CHMP/206166/2016 Summary:

Overview of comments on 'lenalidomide hard gelatine capsules 2.5, 5, 7.5, 10, 15 and 25mg product-specific bioequivalence guidance’ (EMA/CHMP/PKWP/152216/2015)

Draft lenalidomide hard gelatine capsules 2.5, 5, 7.5, 10, 15 and 25mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 01/10/2015 to 01/01/2016 Reference Number: EMA/CHMP/PKWP/152216/2015 Summary:

The European Medicines Agency has decided to routinely publish product-specific bioequivalence guidance for a more consistent approach to the assessment of marketing authorisation applications for generic medicines across all authorisation routes available in the European Union. This guidance document describes the specific requirements for the demonstration of bioequivalence for lenalidomide.