Similar biological medicinal products containing recombinant follicle-stimulating hormone - Scientific guideline
Table of contents
This 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.
Keywords: Follicle stimulating hormone (FSH), similar biological products, comparability, non-clinical studies, clinical studies
-
List item
Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human follicle-stimulating hormone (r-hFSH) (PDF/106.75 KB)
Adopted
First published: 06/03/2013
Last updated: 06/03/2013
EMA/CHMP/BMWP/671292/2010 -
List item
Overview of comments on guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human follicle-stimulating hormone (r-hFSH) (EMA/CHMP/BMWP/671292/2010) (PDF/85.84 KB)
First published: 06/03/2013
Last updated: 06/03/2013
EMA/92876/2013 -
List item
Draft guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human follicle stimulating hormone (r-hFSH) (PDF/159.06 KB)
Draft: consultation closed
First published: 24/11/2011
Last updated: 24/11/2011
Consultation dates: 17/11/2011 to 31/05/2012
EMA/CHMP/BMWP/671292/2010 -
List item
Concept paper on similar biological product containing recombinant follicle stimulation hormone (PDF/125.31 KB)
Draft: consultation closed
First published: 06/04/2010
Last updated: 06/04/2010
Consultation dates: 18/03/2010 to 11/06/2010
EMA/CHMP/BMWP/94899/2010