On 7 April 2025, Teva and Samsung Bioepis announced the US launch of Epysqli® (eculizumab-aagh), biosimilar to Alexion’s Soliris®. According to the joint announcement, Epysqli® will be offered at a 30% discount of the Wholesale Acquisition Cost (WAC) of Soliris®.
This makes Epysqli® the second available eculizumab biosimilar in the US, following the launch of Amgen’s Bkemv® (eculizumab-aeeb) in March 2025. The timing of the US launch of Bkemv® was governed by a settlement reached by Amgen and Alexion in May 2020, permitting launch from 1 March 2025.
Epysqli® was launched in Germany, Italy and Spain in October 2023 and in Korea in April 2024. The UPC (June/July 2024) and the UPC Court of Appeal (December 2024) refused to grant preliminary injunctions against Samsung Bioepis and Amgen in relation to the sale of their eculizumab biosimilars in the EU.