On August 30, 2024, Alexion and Samsung Bioepis filed voluntary dismissals in all of their pending patent proceedings related to Soliris® (eculizumab) biosimilar Epysqli® (eculizumab-aagh), including Case No. 1:24-cv-00005 (D. Del.), CAFC Appeal No. 24-1829 (related to the denial of a preliminary injunction against the commercial launch of Epysqli®), IPR2023-00933 (U.S. Patent No. 9,732,149), IPR2023-00998 (U.S. Patent No. 9,718,880), IPR2023-00999 (U.S. Patent No. 9,725,504), IPR2023-01069 (U.S. Patent No. 10,590,189), and IPR2023-01070 (U.S. Patent No. 10,703,809). All of the IPRs settled after institution. The settlements come shortly after Epysqli®’s July 2024 FDA-approval as an interchangeable biosimilar (see FDA Approves Second Soliris® (eculizumab) Interchangeable Biosimilar – Samsung Bioepis’s Epysqli® (eculizumab-aagh)). Terms of the settlement have not been announced by the companies.
These were the last pending patent proceedings related to a Soliris® biosimilar. In 2020, Alexion settled with Amgen, granting a nonexclusive, royalty-free license as of March 1, 2025, or earlier under certain undisclosed circumstances, for its interchangeable biosimilar Bkemv™ (eculizumab-aeeb), which was FDA-approved in May 2024 (previously reported FDA Approves First Interchangeable Biosimilar of Alexion’s Soliris® (eculizumab) – Amgen’s Bkemv™ (eculizumab-aeeb)). Currently there are no publicly disclosed pending aBLAs for additional Soliris® biosimilars.
AstraZeneca reported Soliris® 2023 worldwide sales of $3.145 billion USD.
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The author would like to thank April Breyer Menon for her contributions to this article.
