Search Results for: "amgen v sandoz"

BREAKING NEWS—Amgen v. Sandoz: Amgen’s Emergency Motion for an Injunction Pending En Banc Consideration and Review

Following the parties’ petitions for rehearing en banc in Amgen v. Sandoz, Amgen has filed an emergency motion for an injunction to block the launch of Sandoz’s FDA-approved biosimilar filgrastim product, pending the Federal Circuit’s en banc consideration and review.  Sandoz is currently enjoined from marketing its biosimilar product, Zarxio,…

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Biologics, Biosimilars, and the Biologics Price Competition and Innovation Act (“BPCIA”): A Short Primer

Below we provide a short introduction to the world of biologics and the BPCIA. For a more comprehensive guide on biosimilars, check out Goodwin Procter’s Biosimilars: A Guide to Regulatory and Intellectual Property Issues. What are biologics? Biologics are medical products such as vaccines, therapeutic proteins, and gene therapies that…

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