Similar biological medicinal products containing recombinant follicle-stimulating hormone

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Current effective version

Adopted guideline

Reference numberCHMP/BMWP/671292/2010
Published06/03/2013
Effective from01/09/2013
KeywordsFollicle stimulating hormone (FSH), similar biological products, comparability, non-clinical studies, clinical studies
DescriptionThis document lays down the non-clinical and clinical requirements for recombinant human follicle stimulating hormone (r-hFSH)-containing medicinal products claiming to be similar to another one already marketed.


Document history

First version

Current version

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 01/09/2013–present


Published: 06/03/2013


Published: 24/11/2011


Published: 06/04/2010


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