Ringside For Zarxio At Supreme Court: Biosimilar Stakeholders Line Up

 
• By Brenda Sandburg
  
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High court set to determine timing of biosimilar marketing and how parties handle patent disputes in Sandoz v. Amgen. Stakeholders say the outcome will impact innovation, access to biosimilars and future litigation.

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The shape of biosimilar litigation for years to come will be on the line April 26 when the Supreme Court hears oral arguments in the Sandoz Inc. v. Amgen Inc. case. Depending on the decision, biosimilar sponsors could face protracted litigation and even launch delays, and with so much on the line, innovator companies, biosimilar applicants and other stakeholders filed a slew of amicus briefs.

The court is to consider two questions about the requirements of the Biologics Price Competition and Innovation Act (BPCIA): Must...

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