Amgen and Accord End Filgrastim, Pegfilgrastim Biosimilar Litigation

On November 14, 2019, the parties in the Amgen v. Accord (previously Apotex) follow-on BPCIA litigation filed a Stipulation of Dismissal, agreeing “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 next day, the district court entered an Order approving the stipulation and closing the case. Neither the papers that the parties publicly filed with the court nor the court’s Order indicates the reasons for the parties’ stipulated dismissal, although the parties filed documents with the court under seal recently.

Accord, the defendant in the lawsuit, was substituted in place of Apotex, the original defendant, in August 2019.  Apotex had filed its aBLAs for proposed filgrastim and pegfilgrastim biosimilars in 2014.  Although Apotex prevailed in its first-wave BPCIA litigation against Amgen concerning U.S. Patent No. 8,952,138, Amgen sued Apotex again in August 2018 for infringement of another patent, U.S. Patent No. 9,856,287.  Neither Apotex nor Accord has obtained FDA approval for either biosimilar candidate.

Download PDF