Similar biological medicinal products containing recombinant follicle-stimulating hormone - Scientific guideline

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

Current effective version

Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human follicle-stimulating hormone (r-hFSH)

AdoptedReference Number: EMA/CHMP/BMWP/671292/2010Summary:

This guideline 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)

Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human follicle-stimulating hormone (r-hFSH)

AdoptedReference Number: EMA/CHMP/BMWP/671292/2010Summary:

This guideline 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.

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)

Reference Number: EMA/92876/2013

Draft guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human follicle stimulating hormone (r-hFSH)

Consultation dates: 17/11/2011 to 31/05/2012Draft: consultation closedReference Number: EMA/CHMP/BMWP/671292/2010Summary:

This guideline 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.

Concept paper on similar biological product containing recombinant follicle stimulation hormone

Consultation dates: 18/03/2010 to 11/06/2010Draft: consultation closedReference Number: EMA/CHMP/BMWP/94899/2010