Sandoz’s Zarzio (filgrastim) would be the first ‘biosimilar’ drug available in the US

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New Drug Approvals

Neupogen vial and syringe

A key advisory committee of the US Food and Drug Administration (FDA) has voted in favour of licencing a copycat version of a biological drug. If approved, Sandoz’s Zarxio (filgrastim) would be the first ‘biosimilar’ drug available in the US.

read at……..http://www.rsc.org/chemistryworld/2015/01/us-poised-approve-first-biosimilar-drug

On 7 January, the FDA’s Oncological Drugs Advisory Committee unanimously cleared Sandoz’ version of filgrastim – marketed as Neupogen by Amgen – for all five indications approved for the Amgen drug. The medication is used to prevent infection and low white blood cell counts caused by chemotherapy.

Systematic (IUPAC) name
Human granulocyte colony stimulating factor
Clinical data
Trade names Neupogen
AHFS/Drugs.com monograph
Legal status
?
Identifiers
CAS number 143011-72-7
ATC code L03AA02
DrugBank DB00099
UNII PVI5M0M1GW Yes
ChEMBL CHEMBL1201567
Chemical data
Formula C845H1343N223O243S9 
Molecular mass 18802.8 g/mol

Filgrastim is a granulocyte colony-stimulating…

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