Amgen at the centre of biosimilars disputes

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Amgen at the centre of biosimilars disputes

Biosimilares/General | Posted 07/04/2017 0 Post your comment

The disputes involve a biosimilar of Amgen’s biosimilar of Roche’s Avastin (bevacizumab) and Amgen’s blockbuster Neulasta (pegfilgrastim) being made by Coherus Biosciences.

Roche’s Genentech filed a complaint in the Delaware District Court in February 2017 charging that Amgen has obstructed its ability to determine whether the manufacture and/or sale of Amgen’s bevacizumab biosimilar would infringe Genentech’s patents.

According to the complaint, Amgen has opted into the Biologics Price Competition and Innovation Act’s (BPCIA) information exchange procedures, also referred to as the ‘patent dance’. However, Genentech says that it has not gained access to certain specific categories of Amgen manufacturing information that allow it to decide whether Amgen’s biosimilar infringes on Genentech’s patents.

Amgen subsequently filed a motion to dismiss under the Federal Circuit’s holding in Amgen vs Sandoz, despite the fact that the Supreme Court review of the Federal Circuit’s decision is still pending, the holding in Amgen vs Sandoz is binding on the district court. The Federal Circuit’s decision held that it is optional for a biosimilar applicant to disclose its biosimilar application [1]. Amgen argued that it would be wrong to distinguish the company for choosing to disclose its application and the court agreed dismissing Genentech’s complaint in its entirety.

Then on 3 March 2017 Amgen filed a trade secret action in a California state court alleging that Coherus BioSciences had poached employees in order to steal proprietary information on Neulasta (pegfilgrastim) to develop its biosimilar.

Denny Lanfear, President and Chief Executive Officer of Coherus, has ‘categorically’ rejected the allegations, saying that ‘Coherus does not need Amgen’s proprietary information to compete or be successful’. He adds that this ‘baseless litigation’ is an effort by Amgen ‘to delay Coherus as a competitor in the pegfilgrastim market’. It would not be the first time that originator companies have been accused of delaying tactics. A recent report found that companies are using citizen petitions submitted to the US Food and Drug Administration (FDA) ‘in a last-ditch effort to hold off competition’ [2].

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Amgen sues Sandoz over filgrastim biosimilar

References
1. GaBI Online - Generics and Biosimilars Initiative. Patent and regulatory exclusivities driving generic and follow-on market availability [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 7]. Available from: www.gabionline.net/Generics/Research/Patent-and-regulatory-exclusivities-driving-generic-and-follow-on-market-availability
2. GaBI Online - Generics and Biosimilars Initiative. Delaying generics using citizen petitions [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 7]. Available from: www.gabionline.net/Generics/Research/Delaying-generics-using-citizen-petitions

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Source: BigMoleculeWatch, Coherus, Justia,RAPS