|Download document||Draft guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues|
|Reference number||EMEA/CHMP/BMWP/42832/2005 Rev. 1|
|Status||draft: consultation closed|
This guideline lays down the non-clinical and clinical requirements for a biological medicinal product claiming to be similar to another one already marketed ('biosimilar').