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Alexion Sues Samsung Bioepis over SB12 Biosimilar to Soliris® (eculizumab)

Jan 3, 2024

Alexion filed a complaint against Samsung in the US District Court for the District of Delaware asserting infringement of six US eculizumab patents.  The allegations relate to Samsung’s abbreviated Biologics License Application (aBLA)  for SB12, its biosimilar to Alexion’s Soliris® (eculizumab), accepted by the US Food and Drug Administration (FDA) on 7 July 2023.  Soliris® is a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) and other conditions.  On 7 July 2023, Samsung provided its 180-day notice of commercial marketing to Alexion.

In August 2023, Amgen appealed Alexion’s successful preliminary injunction order regarding Amgen’s off-label use of its eculizumab biosimilar Bekemv® in Germany.