Filgrastim is a granulocyte colony-stimulating factor (G-CSF) used to stimulate bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy.

The application by Apotex marks the company’s second biosimilar filing in the US and also the second filing for a filgrastim biosimilar in the US. Apotex also has a biosimilar version of Amgen’s Neulasta (pegfilgrastim) under FDA review [1].

Sandoz was the first company to have an application accepted via the abbreviated biosimilars pathway in the US for its filgrastim biosimilar back in July 2014.

This latest announcement brings the total publicly disclosed biosimilars under FDA review to four. Along with Apotex’s biosimilar pegfilgrastim, Celltrion’s infliximab biosimilar [2] and Hospira’s epoetin alfa biosimilar [3] under review.

Apotex already received approval for its filgrastim biosimilar in the European Union (EU) as Grastofil (the same trade name it wants to use in the US) back in October 2013 [4].

Neupogen, whose patents have already expired in both the EU and the US, had approximately US$1 billion in sales during 2014, according to Apotex.

Related article
Biosimilars of filgrastim

References
1.   GaBI Online - Generics and Biosimilars Initiative. Apotex pegfilgrastim biosimilar under FDA review [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 13]. Available from: www.gabionline.net/Biosimilars/News/Apotex-pegfilgrastim-biosimilar-under-FDA-review 
2.   GaBI Online - Generics and Biosimilars Initiative. FDA advisers to consider infliximab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 13]. Available from: www.gabionline.net/Biosimilars/News/FDA-advisers-to-consider-infliximab-biosimilar 
3.   GaBI Online - Generics and Biosimilars Initiative. Hospira submits application to FDA for epoetin alfa biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 13]. Available from: www.gabionline.net/Biosimilars/News/Hospira-submits-application-to-FDA-for-epoetin-alfa-biosimilar 
4.   GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 13]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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