Search Results: test Amgen v. Sandoz (filgrastim)

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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Litigation Update: Case Management Statement in Amgen v. Sandoz (filgrastim, pegfilgrastim)

The parties in Amgen v. Sandoz (N.D. Cal.) (filgrastim and pegfilgrastim) have submitted a joint case management statement regarding the two pending cases between the parties: Case No. 3:14-cv-04741-RS (accused product: Zarxio® (filgrsatim-sndz), which Sandoz launched in September, 2015) and Case No. 3:16-cv-02581-RS (accused product: pegfilgrastim (biosimilar to Amgen’s Neulasta®). The parties…

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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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