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

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

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

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

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

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

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

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

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

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

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 closedReference Number: EMEA/CHMP/BMWP/118264/2007

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

Draft: consultation closedReference Number: EMEA/CHMP/BMWP/496286/2006