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

Posted on

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……..

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/ monograph
Legal status
CAS number 143011-72-7
ATC code L03AA02
DrugBank DB00099
Chemical data
Formula C845H1343N223O243S9 
Molecular mass 18802.8 g/mol

Filgrastim is a granulocyte colony-stimulating…

View original post 764 more words


Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s