Sirolimus product-specific bioequivalence guidance - Scientific guideline

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

Keywords: Bioequivalence, generics, sirolimus

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

Sirolimus coated tablets 0.5, 1 and 2 mg, oral solution 1 mg/ml product-specific bioequivalence guidance - Revision 1

Adopted Reference Number: EMA/151700/2025 Rev. 1*

Document history

Sirolimus coated tablets 0.5, 1 and 2 mg, oral solution 1 mg/ml product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/315231/2014 Legal effective date: 01/12/2015 Summary:

This document provides product-specific guidance on demonstration of bioequivalence of sirolimus

Overview of comments received on ‘draft sirolimus product-specific bioequivalence guidance'

Reference Number: EMA/CHMP/116630/2014

Draft sirolimus product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 15/11/2013 to 15/02/2014 Reference Number: CHMP/PKWP/422569/2013 Summary:

Sirolimus product-specific bioequivalence guidance

Draft sirolimus coated tablets 0.5, 1 and 2 mg, oral solution 1 mg/ml product-specific bioequivalence guidance - Revision 1

Draft: consultation closed Consultation dates: 10/07/2025 to 31/10/2025 Reference Number: EMA/151700/2025 Rev. 1*