On 30 August 2024, Alexion and Samsung Bioepis settled their US proceedings commenced in January 2024 regarding patents covering eculizumab. The parties filed voluntary dismissals in proceedings in the US District Court for the District of Delaware and the Court of Appeal for the Federal Circuit.
In January 2024, Alexion filed a complaint against Samsung Bioepis in the US District Court for the District of Delaware asserting infringement of six US eculizumab patents. The allegations related to Samsung Bioepis’ aBLA for SB12/Epysqli®, its biosimilar to Alexion’s Soliris® (eculizumab), accepted by the US Food and Drug Administration (FDA) in July 2023 and approved in July 2024. In May 2024, the Court refused to grant Alexion preliminary injunctive relief and Alexion appealed the decision to the Court of Appeal. An emergency injunction application pending the appeal was also refused.
The terms of the settlement agreement between Alexion and Samsung Bioepis have not been made public and the launch date of Samsung Bioepis’ eculizumab biosimilar is unknown.
On 28 May 2024, Amgen’s Bkemv® (eculizumab-aeeb) was approved by the FDA as the first interchangeable biosimilar to Alexion’s Soliris®. Bkemv® is set to be launched in the US in March 2025, under a settlement reached by Amgen and Alexion in May 2020.