Brinckerhoff Quoted on Amgen v. Sandoz Decision

23 July 2015 Pharmaceutical Executive News

Pharmaceutical Executive

Partner Courtenay Brinckerhoff was quoted in Pharmaceutical Executive’s article, “Biosimilars: The Next Chapter,” on July 23, 2015. The article discussed the U.S. Court of Appeals for the Federal Circuit’s decision in Amgen v. Sandoz and its impact on the biosimilar sector of the pharmaceutical industry. Brinckerhoff outlined the case milestones and said, “Sandoz first gave notice of its plans to commercially market Zarxio before the FDA had approved its application. Amgen argued that notice was ineffective because the statute requires notice of a ‘licensed’ product, which only can be given once the product is approved. The district court agreed with Sandoz on this issue, but the Federal Circuit agreed with Amgen.”

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