Sandoz, the generics division of Swiss drug giant Novartis, announced on 24 July 2014 that the US Food and Drug Administration (FDA) had accepted its application for approval of the company’s biosimilar filgrastim product. Sandoz already markets its biosimilar filgrastim product, under the brand name Zarzio, in more than 40 countries outside the US [1].

Amgen is suing Sandoz under the claim that the company was not informed of the filing by the deadline of 20 days after FDA informed Sandoz that its application had been accepted for review. Amgen is also saying that Sandoz did not follow the rules of the Biologics Price Competition and Innovation Act (BCPI Act) by giving Amgen a copy of its application. This, Amgen says, prevents them from examining the Sandoz application to see whether it has a patent-infringement case against the biosimilars maker. Amgen has sued Sandoz anyway for patent infringement.

Instead of providing Amgen with its application, Sandoz apparently proposed an alternative procedure in a 8 July 2014 letter to Amgen. Sandoz proposed that the parties exchange certain information without following the BCPI Act process; an offer which Amgen rejected. Sandoz then followed with a letter saying it would not provide its application to Amgen, and finally, in a 20 October 2014 letter, Sandoz allegedly reminded Amgen that Sandoz’s initial 8 July 2014 letter provided Amgen with Sandoz’s 180-day notice of commercial marketing pursuant to the BCPI Act.

In its lawsuit, Amgen wants the court to prevent Sandoz marketing its biosimilar until the two companies resolve patent disagreements. In addition, it wants the court to stop Sandoz’s application from moving forward at FDA and to say that Sandoz cannot notify Amgen of its intention to market the product until after it wins FDA approval. Such a ruling could delay the launch of Sandoz’s biosimilar filgrastim for six months after FDA approval.

But Amgen has not stopped there. In a petition to FDA, Amgen has also asked the agency to require biosimilar applicants – before their applications are accepted for review by FDA – to certify to the agency that they will comply with the BPCI Act by providing the reference product sponsor with a copy of their application within the 20-day deadline.

According to Amgen, the entire fabric of the BPCI Act, including biosimilars exclusivity, is at stake.

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Reference
1.   GaBI Online - Generics and Biosimilars Initiative. FDA accepts biosimilar filgrastim application [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Nov 14]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-biosimilar-filgrastim-application

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