Parallelism of Chemicostructural Properties between Filgrastim Originator and Three of Its Biosimilar Drugs

Table 1

Summary of filgrastim formulations analyzed in this study, including compositions as declared by respective manufacturers and reported on corresponding leaflets.

Medicine name	Granulokine® (30 MU/0.5 ml or 0.6 mg/mL)	Zarzio® (30 MU/0.5 ml or 0.6 mg/mL)	Tevagrastim® (30 MU/0.5 ml or 0.6 mg/mL)	Nivestim™ (30 MU/0.5 ml or 0.6 mg/mL)
Abbreviation	GRA	NIV	TEV	ZAR
Marketing authorization holder	Amgen	Sandoz	Teva	Hospira
Manufacturers of the active substance	Amgen Inc	Sandoz	SICOR Biotech	Hospira
Name of active substance before EMA authorization	Nd	EP2006	XM02	PLD108
Batch number	1057523	4501145	FL5047 F	2063124A
Authorization date	05/2003 by AIFA	02/2009 by EMA	09/2008 by EMA	06/2010 by EMA
Drugs	Filgrastim 300 μg	Filgrastim 300 μg	Filgrastim 300 μg	Filgrastim 300 μg
Excipients	Sodium acetate^#	Acetic acid glacial	Acetic acid glacial	Glutamic acid
		Sodium hydroxide	Sodium hydroxide
	Sorbitol (E420)	Sorbitol (E420)	Sorbitol (E420)	Sorbitol (E420)
	Polysorbate 80	Polysorbate 80	Polysorbate 80	Polysorbate 80
	Water	Water	Water	Water

Italian brand name of Neupogen® approved by FDA on 02/1991. ^#Product by salification of acetic acid glacial with sodium hydroxide.