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.

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