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Samsung Bioepis’ Rare Disease Biosimilar Approved for US

publication date: Jul 24, 2024

South Korea’s Samsung Bioepis announced that its Soliris biosimilar, Epysqli, is approved in the US to treat paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Samsung acquired Epysqli as part of its $39 billion takeover of Alexion in 2020. In 2023, Soliris produced $3.15 billion in 2023 global revenues for AstraZeneca, which was 14% lower than the previous year because Soliris had gone off-patent in Europe. Samsung’s Epysqli is the lead biosimilar in Europe to replace Soliris, where it is also approved for the same two rare diseases, PNH and aHUS. More details....

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