FDA accepts application for pegfilgrastim biosimilar

Biosimilars/News | Posted 04/12/2015 post-comment0 Post your comment

Sandoz, the generics division of Novartis, announced on 18 November 2015 that its regulatory submission for its proposed pegfilgrastim biosimilar had been accepted by the US Food and Drug Administration (FDA).

Application V15a16

Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue filgrastim. It serves to stimulate the level of white blood cells (neutrophils). Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy.

The product is a proposed biosimilar to Amgen’s Neulasta (pegfilgrastim), which had worldwide sales of US$5.8 billion in 2014.  The patents on Neulasta expire in the US in October 2015 and in Europe in August 2017 [1].

Sandoz is seeking approval for its biosimilar in the same indications as the reference product (Neulasta). ‘Sandoz believes that the totality of evidence in its submission, including three pivotal clinical trials – one pharmacokinetic and pharmacodynamic study in healthy volunteers and two comparative efficacy and safety studies in breast cancer patients – will demonstrate that the proposed biosimilar is highly similar to the reference product and therefore justifies use of biosimilar pegfilgrastim in the reference product’s indication.’

This is Sandoz’s third biosimilar application in the US. The company gained US approval for its filgrastim biosimilar, Zarxio (filgrastim-sndz), in March 2015 [2] and has also submitted an application for approval of its etanercept biosimilar (GP2015) to FDA [3]. Zarxio was the first biosimilar to be approved in the US. Sandoz also has three biosimilars approved in the European Union: Binocrit (epoetin alfa), Omnitrope (somatropin) and Zarzio (filgrastim) [4].

Sandoz currently has six biosimilars that are in phase III clinical trials or are undergoing registration, including adalimumab (for patients with autoimmune diseases and based on Humira from AbbVie) and pegfilgrastim.

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1.    GaBI Online - Generics and Biosimilars Initiative. Biologicals patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Dec 4]. Available from: www.gabionline.net/Biosimilars/General/Biologicals-patent-expiries
2.   GaBI Online - Generics and Biosimilars Initiative. Zarxio first biosimilar to be launched in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Dec 4]. Available from: www.gabionline.net/Biosimilars/News/Zarxio-first-biosimilar-to-be-launched-in-US
3.   GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Dec 4]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-etanercept-biosimilar
4.   GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Dec 4]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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