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Alexion and Samsung Bioepis Settle Soliris® Biosimilar Patent Proceedings for Epysqli®

by Robert S. Schwartz, Ph.D.
September 3, 2024

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.

For more information about these and other biosimilar patent proceedings, please visit BiologicsHQ.

 

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The author would like to thank April Breyer Menon for her contributions to this article.

 

    Methodology

    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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