Sitagliptin product-specific bioequivalence guidance - Scientific guideline

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

Keywords: Bioequivalence, generics, sitagliptin

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

Sitagliptin film-coated tablets 25, 50 and 100 mg product-specific bioequivalence guidance - Revision 1

Adopted Reference Number: EMA/188381/2025/Rev. 1 Legal effective date: 01/01/2026

Document history

Sitagliptin film-coated tablets 25, 50 and 100 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/158934/2016 Legal effective date: 01/11/2016 Summary:

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

Overview of comments on Sitagliptin film-coated tablets 25, 50 and 100 mg product-specific bioequivalence guidance

Reference Number: EMA/CHMP/162917/2016 Summary:

Overview of comments on Sitagliptin film-coated tablets 25, 50 and 100 mg product-specific bioequivalence guidance (EMA/CHMP/PKWP/36869/2015)

Draft sitagliptin film-coated tablets 25, 50 and 100 mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 15/07/2015 to 01/11/2015 Reference Number: EMA/CHMP/PKWP/36869/2015 Summary:

The European Medicines Agency has decided to routinely publish product-specific bioequivalence guidance for a more consistent approach to the assessment of marketing authorisation applications for generic medicines across all authorisation routes available in the European Union. This guidance document describes the specific requirements for the demonstration of bioequivalence for sitagliptin.