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Posts tagged Samsung Bioepis
Roche prevails on two IPR challenges to Herceptin patents—does it matter?

We previously wrote about Roche’s encroaching biosimilars for Ritxuan®, Herceptin®, and Avastin®.  This week, Roche prevailed on two IPRs covering patents for Herceptin®, but lost a third IPR covering another patent for the same drug. What does this mean? 

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Did AbbVie create a wrongful “patent thicket” around Humira®?

​​​​​​​Boehringer Ingelheim has claimed that AbbVie wrongfully created a “patent thicket” around Humira®, and it is delaying biosimilar competition.  While that defense is unique, and may be hard to prove on its face, the FDA appears to agree with Boehringer.  Did AbbVie create a wrongful “patent thicket” around Humira®?

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Will AbbVie’s latest patent suit against Sandoz mean a Humira-biosimilar before 2023?

AbbVie ($ABBV) has commenced its latest litigation in its campaign to keep biosimilars for Humira® at bay.  On August 10, AbbVie brought suit against Sandoz ($NVS) asserting that two of AbbVie’s patents will be infringed by Sandoz’s proposed biosimilar.  Sandoz is the fifth biosimilar to throw its hat in the ring.  Does this increase the odds of the US market seeing a biosimilar for Humira® before 2023?

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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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