Everolimus product-specific bioequivalence guidance

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

Keywords: Bioequivalence, generics, everolimus

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

Everolimus tablets 0.25 mg, 0.5 mg, 0.75 mg and 1 mg; 2.5 mg, 5 mg and 10 mg, dispersible tablets 0.1 mg and 0.25 mg; 2 mg, 3 mg and 5 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/151597/2015 Legal effective date: 01/07/2017

Document history

Overview of comments received on ‘Everolimus tablets 0.25 mg, 0.5 mg, 0.75 mg and 1 mg; 2.5 mg, 5 mg and 10 mg, dispersible tablets 0.1 mg and 0.25 mg; 2 mg, 3 mg and 5 mg product-specific bioequivalence guidance’

Reference Number: EMA/CHMP/620299/2016

Draft everolimus tablets 0.25, 0.5, 0.75 and 1mg; 2.5, 5 and 10mg, dispersible tablets 0.1 and 0.25mg; 2, 3 and 5mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 02/05/2016 to 31/07/2016 Reference Number: EMA/CHMP/154772/2016