Guideline on similar biological medicinal products

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

This guideline replaces '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: 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 interferon beta

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

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