Filgrastim - Filgrastim Hexal; Granulocyte Colony Stimulating Factor, recombinant
Status - EU biosimilar approval in Sept. 2008
Organizations involved:
Hexal Biotech Forschungs GmbH - Europe mark.
Sandoz AG – Manuf.; R&D; Tech.
Novartis AG – Parent
Cross ref.: See the entry for G-CSF, rDNA/Sandoz (Zarzio), which is the same product as this, with the product manufactured by Sandoz/Novartis, but marketed and with EU approval held by Hexal. See the filgrastim (Neupogen) for G-CSF-related information.
Description: See the entries for G-CSF, rDNA/Sandoz (Zarzio) for further descriptive information.
Filgrastim Hexal is a formulation of recombinant human G-CSF produced in transformed Escherichia coli (E. coli) bacteria. Its amino acid sequence is identical to that of natural human G-CSF, except for the addition of an N-terminal methionine necessary for the expression in E. coli; and it is not glycosylated. Zarzio composition matches that of Neupogen except for the use of glutamate rather than acetate for the buffer..
Two presentations of the medicinal product are available: 30MU (300 µg/0.5 ml) Solution for Injection/concentration for solution for infusion; and a pre-filled syringe with 48 MU (480 µg/0.5 ml) Solution for Injection/concentrate for solution for infusion. The reference product, Neupogen, is also available in these same two presentations. Each ml of solution contains 60 million units (MU; equivalent to 600 µg filgrastim). Each pre-filled syringe contains 30 MU (equivalent to 300 µg) filgrastim in 0.5 ml. Each ml of solution also contains 50 mg sorbitol. The product has a shelf life of shelf-life of 30 months at 5±3°C for both presentations.
Biological.: See the entry for G-CSF, rDNA/Sandoz (Zarzio), which is the same product as this.
Nomenclature: G-CSF, rDNA/Hexal [BIO]; Filgrastim Hexal [TR]; Filgrastim [USAN INN BAN MESH]; colony-stimulating factor (human clone 1034) , N-L-methionyl- [CAS]; 135968-09-1 [CAS RN]; granulocyte colony stimulating factor, recombinant [SY]; r-metHuG-CSF [SY]; NSC 614629 [SY NCI]
Companies.: Filgrastim Hexal was developed and is manufactured and marketed by Sandoz AG (Vienna, Austria), the generics subsidiary of Novartis AG. Filgrastim Hexal is manufactured and released at Sandoz GmbH, Kundl, Austria. Figrastim Hexal is marketed in Europe by Hexal.
Manufacture: See the entry for G-CSF, rDNA/Sandoz (Zarzio), which is the same product as this. Filgrastim is manufactured and released at Sandoz GmbH, Kundl, Austria
Status: A MAA for biosimilar approval with Neupogen as the reference was filed on Sept. 6, 2007. The MAA was submitted by Hexal under 2001/83/EC Article 10(4) concerning biosimilar medicinal products. European Union biosimilar approval was granted on Feb. 6, 2009 (Procedure No. EMEA/H/C/000918).
Trials: See the entry for G-CSF, rDNA/Sandoz (Zarzio), which is the same product as this.
Market: Filgrastim Hexal will have to compete against Neupogen and multiple other biosimilars and also against Neulasta (pegylated G-CSF). If G-CSF biosimilars follow the examples set by biosimilar EPO products, these products will only capture relatively small market share in Europe.
Index Terms:
Companies involvement:
Full monograph
160.3 G-CSF, rDNA/Hexal
Nomenclature:
G-CSF, rDNA/Hexal [BIO]
Filgrastim [USAN INN BAN MESH]
colony-stimulating factor (human clone 1034) , N-L-methionyl- [CAS]
135968-09-1 [CAS RN]
granulocyte colony stimulating factor, recombinant [SY]
NSC 614629 [SY NCI]
molecular weight (kDa) = 19
FDA Class: Biologic BLA
biopharmaceutical products
Biorex-70 resin
exempt from CBER lot release requirements
growth factors, hematopoietic
recombinant DNA
bacterial culture <!-- bacterialculture -->
Escherichia coli (E. coli)
polysorbate 80 (Tween 80)
sodium acetate
somatropin, recombinant
BHK-21 (C-13)
EU200 Currently Approved in EU EU777
UM999 Not Available/Not Marketed in US
US000 never filed/no plans
EM001 Marketed Product in EU
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