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Posts tagged Neupogen
Will Amgen's latest Neulasta® patent loss against Sandoz read-through to other biosimilars?

Sandoz recently prevailed in court against Amgen by showing it does not infringe a patent covering two of Amgen’s drugs, Neulasta® and Neupogen®.  No biosimilar has yet to receive FDA approval for Neulasata® within the U.S.  Sandoz recently announced successful Phase 1 data indicating it may be getting closer.  Further, other biosimilars for Neulasta® are in the works.  Given that Neulasta® accounts for a third of Amgen’s sales, will Amgen’s recent loss in its case against Sandoz read-through to other biosimilars?

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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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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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