Table 3.

European guidelines for the development and evaluation of biosimilar medicines [52].

Type of Guideline	Guideline Title
General	Guideline on similar biological medicinal products.
	Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: quality issues.
	Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: clinical and non-clinical issues.
Specific	Guideline on biosimilar medicines containing recombinant granulocyte colony-stimulating factor.
	Guideline on clinical and non-clinical development of similar medicines containing low-molecular-weight heparins.
	Guideline on clinical and non-clinical development of similar medicines containing recombinant human insulin and insulin analogue.
	Guideline on clinical and non-clinical development of similar medicines containing beta interferon.
	Guideline on clinical and non-clinical development of similar medicines containing monoclonal antibodies: ethical and non-clinical issues.
	Guideline on clinical and non-clinical development of similar medicines containing recombinant erythropoietin.
	Guideline on clinical and non-clinical development of similar medicines containing the recombinant follicle-stimulating hormone.
	Guideline on clinical and non-clinical development of similar medicines containing somatropin.
Others	Comparability of biotechnology-derived medicinal products after a change in manufacturing process: clinical and non-clinical issues.
	ICH Q5E biological/biotechnology products subject to changes in their manufacturing processes: comparability of biological/biotechnology products.