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

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Current effective version

Adopted guideline - Revision 1

Reference numberEMEA/CHMP/BMWP/118264/2007 Rev. 1
Effective from01/06/2017
KeywordsLow molecular weight heparins, low molecular mass heparins, similar biological medicinal products, biosimilar, comparability, quality, non-clinical studies, clinical studies, extrapolation
DescriptionThis 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.

Document history

Revision 1

Current version


Adopted guideline




Draft guideline

Concept paper

Published: 24/11/2016


Effective from: 01/06/2017


Published: 31/01/2013

Published: 27/07/2011

First version

Adopted guideline

Overview of comments

Draft guideline

Concept paper

In operation: 01/10/2009 - 01/06/2017

Published: 17/11/2009

Published: 24/04/2008

Published: 24/01/2007

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