Amgen and Kashiv Ask District Court to Dismiss Their Filgrastim Biosimilar Litigation

On November 22, 2019, the parties in the Amgen v. Kashiv BPCIA litigation, concerning Kashiv’s proposed biosimilar of NEUPOGEN (filgrastim), submitted a stipulation of dismissal indicating that they have “agree[d] to the dismissal, without prejudice, of all remaining claims and counterclaims in this action with the parties to bear their own costs and attorney’s fees.”  If the stipulation is entered by the district court, the case will be dismissed.  The parties did not explain their reasoning for seeking dismissal in their publicly filed papers.  Kashiv’s filgrastim biosimilar candidate has not received FDA approval.

This dismissal stipulation follows a flurry of case-ending events this year in Amgen’s filgrastim and pegfilgrastim biosimilar litigations.  The stipulation comes on the heels of a similar dismissal stipulation last week in Amgen v. Accord, which ended the litigation concerning Accord’s (previously Apotex’s) proposed filgrastim and pegfilgrastim biosimilars.  Earlier this year, Amgen lost its Federal Circuit appeals in Amgen v. Sandoz, concerning Sandoz’s filgrastim and pegfilgrastim biosimilars, and in Amgen v. Coherus, concerning Coherus’s pegfilgrastim biosimilar.  In addition, in September 2019, Amgen and Mylan filed a stipulation of non-infringement regarding Mylan’s pegfilgrastim biosimilar.  Amgen’s filgrastim biosimilar litigations against Pfizer and Tanvex, however, remain pending in district court.  The Pfizer case is set for trial on June 15, 2020, whereas the Tanvex case has a January 26, 2021 trial date.