Non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight heparins - Scientific guideline

This document lays down the non-clinical and clinical requirements for low molecular weight heparins (LMWHs, low molecular mass heparins, LMMH) containing medicinal products claiming to be similar to another one already marketed.

Keywords: Low molecular weight heparins, low molecular mass heparins, similar biological medicinal products, biosimilar, comparability, quality, non-clinical studies, clinical studies, extrapolationocument history

Current effective version

Guideline on non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight-heparins - Revision 1

Adopted Reference Number: EMEA/CHMP/BMWP/118264/2007 Rev. 1 Summary:

This guideline lays down the non-clinical and clinical requirements for low molecular weight heparins (= low molecular mass heparins, LMWHs) containing medicinal products claimed to be biosimilar to another one already marketed. The quality section addresses some aspects specific to LMWH, the non-clinical section addresses the pharmaco-toxicological requirements and the clinical section the requirements for pharmacokinetic, pharmacodynamic and, where needed, safety/immunogenicity studies as well as pharmacovigilance aspects.

Document history - Revision 1 (current version)

Guideline on non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight-heparins - Revision 1

Adopted Reference Number: EMEA/CHMP/BMWP/118264/2007 Rev. 1 Summary:

This guideline lays down the non-clinical and clinical requirements for low molecular weight heparins (= low molecular mass heparins, LMWHs) containing medicinal products claimed to be biosimilar to another one already marketed. The quality section addresses some aspects specific to LMWH, the non-clinical section addresses the pharmaco-toxicological requirements and the clinical section the requirements for pharmacokinetic, pharmacodynamic and, where needed, safety/immunogenicity studies as well as pharmacovigilance aspects.

Draft guideline on non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight heparins

Draft: consultation closed Consultation dates: 31/01/2013 to 31/07/2013 Reference Number: EMEA/CHMP/BMWP/118264/2007 Rev. 1 Summary:

This guideline lays down the non-clinical and clinical requirements for low-molecular-weight-heparin (LMWH)-containing medicinal products claiming to be similar to another one already marketed. The non-clinical section addresses the pharmacotoxicological requirements and the clinical section the requirements for pharmacokinetic, pharmacodynamic, efficacy and safety studies as well as pharmacovigilance aspects.

Concept paper on the revision of the guideline on nonclinical and clinical development of similar biological medicinal products containing low-molecular-weight heparins

Draft: consultation closed Consultation dates: 21/07/2011 to 30/09/2011 Reference Number: EMA/CHMP/BMWP/522386/2011 Summary:

The Guideline on Similar Medicinal Products containing Low-Molecular-Weight Heparins (LMWH) lays down the non-clinical and clinical requirements for the development of LMWH claimed to be similar to a reference product already authorised in the EU. This guideline came into effect in October 2009. So far, no biosimilar LMWH has been licensed in the EU.

Document history - First version

Guideline on non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight-heparins

Adopted Reference Number: EMEA/CHMP/BMWP/118264/2007 Legal effective date: 01/10/2009

Overview of comments received on draft guideline on similar biological medicinal products containing low-molecular-weight-herapins

Reference Number: EMEA/582443/2008

Draft guideline on similar biological medicinal products containing low-molecular-weight-heparins

Draft: consultation closed Reference Number: EMEA/CHMP/BMWP/118264/2007

Draft concept paper on similar biological medicinal products containing low molecular weight heparins1 - (non) clinical issues

Draft: consultation closed Reference Number: EMEA/CHMP/BMWP/496286/2006