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Posts tagged Erelzi
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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