Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues

Concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues

Concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues

Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1)

Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues

Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant erythropoietins (Revision)

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