Sandoz gained approval for Zarxio on 6 March 2015 from the US Food and Drug Administration (FDA). Sandoz’s filgrastim biosimilar has been approved in all five indications of Amgen’s originator product (Neupogen) [1].

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.

US District Judge Richard Seeborg said in his ruling that the dispute between the drugmakers hinged on conflicting interpretations of the Biologics Price Competition and Innovation Act (BPCIA), the 2009 law that allows for abbreviated approval of biosimilars. He also dismissed Amgen’s claim that Sandoz violated the BPCIA when it gave Amgen its 180-day notice of intent to market Zarxio in advance of FDA approving the biosimilar.

Judge Seeborg said that Sandoz was not required to provide the disclosures and engage in the dispute-resolution process set out by the BPCIA.

Ms Kristen Davis, a spokeswoman for Amgen said that the company was ‘disappointed in the district court’s decision and will seek review by the appeals court’. Novartis, on the other hand, welcomed the court’s decision and was looking forward to introducing filgrastim as the first US biosimilar.

Amgen filed an appeal in the US Court of Appeals for the Federal Circuit (CAFC) on 25 March 2015. This would delay Sandoz’s launch of Zarxio until the CAFC resolves the appeal. The district court hearing is scheduled for 30 April 2015, but both companies have requested a hearing date as early as 2 April 2015.

Sandoz has agreed not to launch Zarxio in the US until 11 May 2015, unless a ruling by the CAFC is reached earlier on Amgen’s appeal.

There is much at stake; Neupogen generated an estimated US$1.2 billion in sales for Amgen in 2014.

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FDA advisers recommend approval of filgrastim biosimilar

Reference
1.   GaBI Online - Generics and Biosimilars Initiative. FDA approves its first biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 27]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-its-first-biosimilar 

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