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FDA Approves Second Soliris® (eculizumab) Interchangeable Biosimilar – Samsung Bioepis’s Epysqli® (eculizumab-aagh)

by Robert S. Schwartz, Ph.D.
July 24, 2024

On July 19, 2024, the FDA approved the second biosimilar of Alexion / AstraZeneca’s Soliris® (eculizumab), Samsung Bioepis’s Epysqli® (eculizumab-aagh), approximately one year after Samsung Bioepis announced the FDA acceptance of its aBLA.  Epysqli® was approved as an interchangeable.  The FDA previously approved Amgen’s Bkemv™ (eculizumab-aeeb) as an interchangeable to Soliris® in May 2024 (previously reported FDA Approves First Interchangeable Biosimilar of Alexion’s Soliris® (eculizumab) – Amgen’s Bkemv™ (eculizumab-aeeb)).  Like Bkemv™, Epysqli® was approved with a skinny label for paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).

Samsung Bioepis currently has five instituted IPRs (IPR2023-00933, IPR2023-00998, IPR2023-00999, IPR2023-01069, IPR2023-01070) and a pending BPCIA litigation (1:24-cv-00005 (D. Del.)) related to Epysqli® (previously reported BPCIA Complaint Against Proposed Soliris® (eculizumab) Biosimilar SB12 Filed).  In May 2024, the Court denied Alexion’s motion for a preliminary injunction against the commercial launch of Epysqli®.  In the related appeal (CAFC Appeal No 24-1829), Alexion filed a motion for a temporary injunction pending appeal in June and briefing is ongoing.

Under a settlement agreement, Amgen has agreed to a non-exclusive, royalty-free license to market Bkemv™ for the PNH indication starting March 1, 2025, or earlier in certain undisclosed circumstances.  Additional terms of the settlement were not disclosed.

AstraZeneca reported Soliris® 2023 worldwide sales of $3.145 billion USD.

For more information about these and other biosimilar aBLAs and patent disputes, 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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