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Is the biosimilar dance party mandatory?

Peter Leung, Washington DC

The Federal Circuit heard oral arguments this week in Amgen v Sandoz, and the dispute centres on a seemingly simple question that goes to a key part of the Biologics Price Competition and Innovation Act: what does “shall” mean?

Amgen v Sandoz involves Amgen’s biologic Neupogen and Sandoz’s biosimilar version Zarxio.

The Biologics Price Competition and Innovation Act (BPCIA) provides for an expedited pathway for Food and Drug Administration (FDA) approval of biosimilars - these applicants are often referred...

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