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Posts tagged Enbrel
How long can Roche keep back biosimilars for Avastin®, Herceptin® or Rituxan®?

The biosimilars are biting.  And they are biting at three big biologics distributed by Roche through its biotech subsidiary, Genentech.  Roche currently faces pending biosimilar competition against Avastin® (bevacizumab), Roche’s biggest selling cancer drug, Herceptin® (trastuzmab), Roche’s breast-cancer drug, and Rituxan® (rituximab), Roche’s immunotherapy drug.  All three drugs are involved in patent litigations. How long will these cases last? And how long can Roche keep the biosimilars out?

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Why is Amgen doubling-down on its psoriasis patents in the Enbrel® patent case against Sandoz?

The much-anticipated trial in the biosimilar litigation over Enbrel® has been pushed from April, to June and now to September.  Although Amgen ($AMGN) has asserted five patents against Sandoz’s ($NVS) proposed biosimilar, Erelzi®, the focus of the case are the two Roche patents directed to the entanercept protein itself.  And yet, a skirmish has erupted related to one of the three other patents, which collectively cover indications for using entanercept to treat psoriasis indications.

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Coherus denied institution on Enbrel® IPRs – how does that affect Sandoz?

The PTAB has denied institution of two IPRs filed by Coherus Biosciences against patents covering Enbrel®’s proteins, the ‘182 and ‘522 patents.  The IPRs were not filed by Sandoz, but they will most likely affect Sandoz.  Sandoz already has FDA approval to market Erelzi®, which is its biosimilar for Enbrel®.  And Sandoz is going to trial against Amgen in April.  How do Coherus IPR decisions affect Sandoz's decision to launch at risk?  Or to settle with Amgen?

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When do biosimilars launch at risk?

The biosimilar statute, Biologics Price Competition and Innovation Act (BPCIA, was passed in 2010.  Since then, drug companies have been filing biosimilar applications with FDA.  And even though, FDA has approved only nine biosimilar drugs today, an interesting trend may be emerging: biosimilars may be more willing to launch at-risk than small-molecule generics.

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Can Coherus invalidate Amgen's Enbrel® patents? Part 2

In an earlier post, we discussed the pending IPRs filed by Coherus Biosciences against Amgen’s two patents covering its Enbrel® protein (entanercept).  Whereas our earlier post summarized Coherus’s argument for why the fusion protein claimed in Amgen’s ‘182 and ‘522 patents should be found obvious by the PTAB, this post will summarize Amgen’s preliminary response. 

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Sandoz’s aBLA for HUMIRA® has been accepted by FDA -- what happens next?

Sandoz, the generic arm of Novartis, has announced that its abbreviated Biologic License Application (aBLA) for a Humira® biosimilar has been accepted by FDA.  Now that Sandoz’s aBLA has been accepted for review by FDA, what happens next on the patent front? 

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Can Coherus invalidate Amgen’s Enbrel® patents?

Amgen’s Enbrel® blockbuster faces encroaching biosimilar competition from Sandoz and Coherus Biosciences.  Coherus Biosciences has filed petitions for inter partes review against Amgen’s two protein patents covering Enbrel®, the ‘182 patent and the ‘522 patent.  The institution decisions are due before the trial:  March 15, 2018 for the ‘182 IPR, and March 13, 2018 for the ‘522 IPR.  If the IPRs are instituted, that could shift the dynamics, and push the parties to agree on an entry date.  What are Coherus's invalidity arguments?

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Does Sandoz have a double-patenting defense to Amgen’s Enbrel® patents?

In February 2016, Amgen brought suit against Sandoz in connection with its proposed biosimilar for Amgen’s Enbrel® blockbuster.  The case is on a relatively fast track, currently scheduled to go to trial later this year in April.  Some investors have inquired about whether Sandoz has a strong obviousness-type double-patenting invalidity defense for the ‘182 patent.

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