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  |
| ChEMBL | CHEMBL1201567 |
| Chemical data | |
| Formula | C845H1343N223O243S9 |
| Molecular mass | 18802.8 g/mol |
Filgrastim is a granulocyte colony-stimulating…
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DRUG REGULATORY AFFAIRS INTERNATIONAL 