Polsinelli Podcast - Federal Circuit Delays Sandoz Biosimilar Launch

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n a closely-watched case between Amgen and Sandoz regarding the first biosimilar approved (Zarxio), the Federal Circuit interpreted key Biologics Price Competition and Innovation Act (BPCIA) provisions regarding Sandoz’s obligation to disclose information related to its application, and whether Sandoz could effectively provide notice of commercial marketing before FDA approval.

The Federal Circuit decided that certain information-sharing See more +

n a closely-watched case between Amgen and Sandoz regarding the first biosimilar approved (Zarxio), the Federal Circuit interpreted key Biologics Price Competition and Innovation Act (BPCIA) provisions regarding Sandoz’s obligation to disclose information related to its application, and whether Sandoz could effectively provide notice of commercial marketing before FDA approval.

The Federal Circuit decided that certain information-sharing requirements of the BPCIA are optional, because Amgen, the reference product sponsor (RPS) in this case, can obtain such information through discovery following suit for patent infringement, and that is the sole remedy contemplated by the BPCIA.

In this week's Polsinelli Podcast, Intellectual Property Attorney Morgan Kirley discusses the specifics of the Federal Circuit's conclusions and its impact on biosimilar applicants. For more information about the firm go to www.polsinelli.com

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