Second Apotex biosimilar under FDA review

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Sign up
eng / esp

Second Apotex biosimilar under FDA review

Biosimilars/News | Posted 13/03/2015 0 Post your comment

Canada-based Apotex announced on 13 February 2015 that the US Food and Drug Administration (FDA) had accepted for filing the company’s application for a biosimilar version of Amgen’s Neupogen (filgrastim).

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Source: Apotex