Search Results for: "amgen v sandoz"

Analysis of Amgen v. Sandoz Federal Circuit Opinion

Earlier today, the Federal Circuit Court of Appeals issued its long-awaited decision in the remand of Amgen v. Sandoz from the U.S. Supreme Court.  In that decision, the Federal Circuit held that Amgen’s state law claims, based on the failure to follow procedures of the BPCIA patent dance, “are preempted on both field and…

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BPCIA Litigation Roundup (Fall 2017)

Below is our fall update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates (Summer 2016, Fall 2016, Midwinter 2017, Spring 2017, Summer 2017).

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Updates on Sandoz's Pegfilgrastim Biosimilar / Amgen v. Sandoz

Today, Sandoz announced that its biosimilar of Neulasta® (pegfilgrastim) has been accepted by the European Medicines Agency (EMA) for regulatory review.  According to the press release, the data package submitted as part of the Marketing Authorization Application “strongly demonstrates that the biosimilar pegfilgrastim matches the reference medicine in terms of safety,…

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