Fingolimod product-specific bioequivalence guidance

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

Keywords: Bioequivalence, generics, fingolimod

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 version - effective 1 January 2026

Fingolimod capsules 0.25 and 0.5 mg product-specific bioequivalence guidance - Revision 1

Adopted Reference Number: EMA/CHMP/154812/2016 Rev.1 Legal effective date: 01/01/2026

Document history

Fingolimod capsules 0.25 and 0.5 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/154812/2016 Legal effective date: 01/07/2017

Overview of comments received on 'Fingolimod capsules 0.5 mg product-specific bioequivalence guidance'

Reference Number: EMA/CHMP/805860/2016

Draft Fingolimod capsules 0.5mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 02/05/2016 to 31/07/2016 Reference Number: EMA/CHMP/154812/2016