On April 7, 2025, Samsung Bioepis and Teva announced the launch of Epysqli® (eculizumab-aagh), a provisionally interchangeable biosimilar of Alexion / AstraZeneca’s Soliris® (eculizumab), at a 30% discount to Soliris®’s wholesale acquisition cost. In March, Amgen launched its interchangeable biosimilar Bkemv™ (eculizumab-aeeb) at approximately a 10% discount. These are the first Soliris® biosimilars to launch in the U.S. Both companies launched their biosimilars pursuant to settlement agreements (see Alexion and Samsung Bioepis Settle Soliris® Biosimilar Patent Proceedings for Epysqli®).
There have not been any other publicly announced aBLAs for additional Soliris® biosimilars, and there are no ongoing patent proceedings.
AstraZeneca reported Soliris® U.S. sales of $1.523B USD in FY24.
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The author would like to thank April Breyer Menon for her contributions to this article.
