Analysis

3 Takeaways As Fed. Circ. Limits Biosimilar Lawsuits

Law360, New York (December 14, 2017, 9:21 PM EST) -- The Federal Circuit on Thursday averted potential chaos by not letting drugmakers use a wide variety of state laws to extract biosimilar manufacturing information from rivals, and its ruling will turn attention to what sort of information rivals must provide under federal law.

Here are three takeaways from the eagerly awaited decision.

Ruling Removes 'Shadow' of State Law Liability

Thursday's ruling marked the latest interpretation of the Biologics Price Competition and Innovation Act, which governs biosimilar litigation and approvals. It found that Amgen Inc. can't wield state laws to punish Sandoz Inc. for not disclosing its biosimilar approval application and manufacturing...

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