Deferasirox product-specific bioequivalence guidance

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

Keywords: Bioequivalence, generics, deferasirox

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

Deferasirox film-coated tablets 90 mg, 180 mg and 360mg, granules 90 mg, 180 mg and 360 mg productspecific bioequivalence guidance - Revision 1

Adopted Reference Number: EMA/CHMP/472383/2020 Rev. 1 Legal effective date: 01/01/2026

First version - Effective from 01/01/2022 until 31/12/2025

Deferasirox, dispersible tablets (125 mg, 250 mg and 500 mg), film-coated tablets (90 mg, 180 mg, and 360 mg), and granules (90 mg, 180 mg and 360 mg) product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/472383/2020 Legal effective date: 01/01/2022

Overview of comments received on 'Draft deferasirox, dispersible tablets (125 mg, 250 mg and 500 mg), film-coated tablets (90 mg, 180 mg, and 360 mg), and granules (90 mg, 180 mg and 360 mg) product-specific bioequivalence guidance'

Reference Number: EMA/CHMP/209314/2021

Draft deferasirox, dispersible tablets (125 mg, 250 mg and 500 mg), film-coated tablets (90 mg, 180 mg, and 360 mg), and granules (90 mg, 180 mg and 360 mg) product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 18/12/2020 to 31/03/2021 Reference Number: EMA/CHMP/472383/2020