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Settlement for Udenyca and win for Zarxio Posted 31/05/2019

Amgen has made a settlement with respect to pegfilgrastim biosimilar Udenyca, but has lost its appeal against filgrastim biosimilar Zarxio.

Coherus Biosciences (Coherus) announced on 2 May 2019 that it had settled the trade secret action brought against Coherus by Amgen regarding Udenyca (pegfilgrastim-cbqv), a biosimilar of Amgen’s Neulasta (pegfilgrastim).

Coherus received US Food and Drug Administration (FDA) approval for Udenyca in November 2018 [1]. Although Coherus said that the details of the settlement were confidential, the company will continue to market Udenyca and ‘will pay a mid-single digit royalty to Amgen for five years’.

Then on 8 May 2019, the US Court of Appeals for the Federal Circuit rejected an appeal from Amgen in patent litigation relating to two Sandoz biosimilars. The case was regarding Sandoz’s biosimilars of Amgen’s cancer drugs Neupogen (filgrastim) and Neulasta (pegfilgrastim).

Amgen had claimed that the biosimilars infringed on an Amgen patent and had called for sales of Zarxio to be halted. The court, however, ruled that neither Zarxio (filgrastim) nor a proposed next-generation biosimilar of Amgen’s Neulasta, would infringe on an Amgen patent for a method of purifying proteins.

Sandoz, the generics division of Novartis, received FDA approval for Zarxio, as the first US-approved biosimilar, back in March 2015 [2] and resubmitted its biosimilar pegfilgrastim (LA-EP2006) application to FDA in April 2019 [3]. The company has been engaged in litigation with Amgen ever since it informed Amgen of its filgrastim biosimilar application. The case hinges on how the companies have interpreted wording in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) regarding the 180-day notice, which has often been referred to as the ‘patent dance’ [4]. Sandoz did not provide Amgen with a copy of its marketing application for its filgrastim biosimilar (Zarxio) and simply provided notice before its product was licensed. Amgen subsequently sued Sandoz, saying that the company had not followed the rules of the BCPI Act [5].

This ruling hopefully draws a line under the whole ‘patent dance’, but only time, and lack of litigation, will tell.

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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves adalimumab and pegfilgrastim biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 31]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-adalimumab-and-pegfilgrastim-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves its first biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 31]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-its-first-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pegfilgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 31]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-pegfilgrastim
4. GaBI Online - Generics and Biosimilars Initiative. How will the timing of BPCI Act 180-day notice affect biosimilars? [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 31]. Available from: www.gabionline.net/Policies-Legislation/How-will-the-timing-of-BPCI-Act-180-day-notice-affect-biosimilars 
5. GaBI Online - Generics and Biosimilars Initiative. Amgen sues Sandoz over filgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 31]. Available from: www.gabionline.net/Biosimilars/News/Amgen-sues-Sandoz-over-filgrastim-biosimilar

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Source: Bloomberg, Coherus, US Court of Appeals

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