On 10 January 2025, Samsung Bioepis and Teva announced they have entered into a licence, development and commercialisation agreement for Epysqli® (eculizumab-aagh), biosimilar to Alexion’s Soliris® (eculizumab), in the US.
Under the agreement, Samsung Bioepis will be responsible for the development, regulatory registration, manufacture and supply of the product, while Teva will be responsible for its US commercialisation.
Epysqli® (SB12) was approved in the US in July 2024 for paroxysmal nocturnal haemoglobinuria and atypical haemolytic uremic syndrome, making it the second eculizumab biosimilar approved by the FDA, following the approval of Amgen’s Bkemv® (eculizumab-aeeb) in May 2024. Epysqli® was launched in Germany, Italy and Spain in October 2023 and in Korea in April 2024. Samsung Bioepis is currently embroiled in UPC patent litigation in Europe, brought by Alexion, in respect of Epysqli®.