Lexology July 24, 2024
Venable LLP

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...

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Topics: Biotechnology, FDA, Govt Agencies, Pharma / Biotech
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