Another Biosimilar Litigation Settlement: Amgen v. Tanvex (Filgrastim)

Following last month’s dismissal of the Amgen v. Kashiv filgrastim biosimilar litigation, yesterday Amgen and Tanvex filed a joint stipulation of dismissal in their BPCIA litigation concerning Tanvex’s filgrastim biosimilar candidate. The stipulation states that the parties agree “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.” The suit was relatively new, having been filed in July 2019, and was not far along. The district court had only just recently entered a scheduling order that called for a trial in January 2021.

If and when the district court endorses the parties’ stipulation and orders dismissal, only four BPCIA litigations will remain pending in district courts:

  1. Amgen v. Hospira, Civil Action No. 18-1064 (D. Del.), concerning Hospira’s NIVESTYM (filgrastim-aafi), a biosimilar of NEUPOGEN;
  2. Genentech v. Amgen, Civil Action Nos. 17-1407, 17-1471, 19-602 (D. Del.), concerning Amgen’s MVASI (bevacizumab-awwb), a biosimilar of AVASTIN;
  3. Genentech v. Amgen, Civil Action No. 18-924 (D. Del.), concerning Amgen’s KANJINTI (trastuzumab-anns), a biosimilar of HERCEPTIN; and
  4. Immunex v. Samsung Bioepis, Civil Action No. 19-11755 (D.N.J.), concerning Samsung Bioepis’s ETICOVO (etanercept-ykro), a biosimilar of ENBREL.

Three other BPCIA litigations are pending on appeal before the Federal Circuit:

  1. Janssen v. Celltrion, Case No. 18-2321 (cons.), concerning Celltrion’s and Hospira’s INFLECTRA (infliximab-dyyb), a biosimilar of REMICADE;
  2. Immunex v. Sandoz, Case No. 20-1037, concerning Sandoz’s ERELZI (etanercept-szzs), a biosimilar of ENBREL;
  3. Amgen v. Hospira, Case No. 19-1067, concerning Hospira’s RETACRIT (epoetin alfa-epbx), a biosimilar or EPOGEN. (This appeal was recently decided by a Federal Circuit panel, but the panel’s decision could potentially be challenged by a petition for panel rehearing and/or rehearing en banc to the Federal Circuit, and/or a petition for certiorari to the U.S. Supreme Court.)