8 / 19
EMEA guidelines for biosimilars authorization
Recombinant
Rituxi, etc.
Guideline on Similar Biological Products Containing Biotechnology-
derived Proteins as Active Substance:
Quality Issues
Guideline on Similar Biological Products Containing
Biotechnology-derived Proteins as Active Substance:
Non-Clinical and Clinical Issues
recombinant
Erythro, G-CSF
Recombinant
Trastu, Beva,
recombinant
hGH, insulin
General
Calidad
Estudios
preclínicos y
clínicos
Anexos y
actualizaciones
Guideline on
Similar Biological Medicinal Products