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 from 01/01/2022

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

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

Overview of comments received on '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' (EMA/CHMP/472383/2020)

Reference Number: EMA/CHMP/209314/2021

Document history

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 closedConsultation dates: 18/12/2020 to 31/03/2021Reference Number: EMA/CHMP/472383/2020

Abbreviations

• BCS Classification: Biopharmaceutics Classification System
• AUC0-t: area under the plasma concentration curve from administration to last observed concentration at time t
• AUC0-72: area under the plasma concentration curve from administration to last observed concentration at 72 hours
• Cmax: maximum plasma concentration