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,…
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…