Lanreotide acetate product-specific bioequivalence guidance

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

Keywords: Bioequivalence, generics, lanreotide acetate

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 1/07/2023

Lanreotide acetate, prolonged-release solution for injection in prefilled syringe 60, 90 and 120 mg productspecific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/559891/2021 Legal effective date: 01/07/2023

Document history

Lanreotide acetate, prolonged-release solution for injection in prefilled syringe 60, 90 and 120 mg productspecific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/559891/2021 Legal effective date: 01/07/2023

Overview of comments on 'Draft lanreotide acetate, prolonged-release solution for injection in prefilled syringe 60, 90 and 120 mg product specific bioequivalence guidance'

Reference Number: EMA/CHMP/839131/2022

Draft lanreotide acetate, prolonged-release solution for injection in prefilled syringe 60, 90 and 120 mg product specific bioequivalence guidance

Draft: consultation closed Consultation dates: 17/05/2022 to 31/08/2022 Reference Number: EMA/CHMP/559891/2021