Ledipasvir/sofosbuvir product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg.

Keywords: Bioequivalence, generics, ledipasvir/sofosbuvir

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

Ledipasvir/sofosbuvir film-coated tablet 45 mg/200 mg and 90 mg/400 mg, coated granules 33.75mg/150mg and 45mg/200mg product-specific bioequivalence guidance - Revision 1

Adopted Reference Number: EMA/151702/2025 Rev. 1*

Document history

Draft ledipasvir/sofosbuvir film-coated tablet 45 mg/200 mg and 90 mg/400 mg, coated granules 33.75mg/150mg and 45mg/200mg product-specific bioequivalence guidance - Revision 1

Draft: consultation closed Consultation dates: 10/07/2025 to 31/10/2025 Reference Number: EMA/151702/2025 Rev. 1

Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/800789/2017 Summary:

Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance

Draft ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 31/01/2018 to 30/04/2018 Reference Number: EMA/CHMP/800789/2017 Summary:

Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance