Alexion Dodges Soliris Biosimilar Bullet For Now With Amgen Patent Settlement

After getting burned by an activist investor calling for a sale, Alexion has found itself defending its corporate strategy. But one area where Alexion has exceeded expectations is in backstopping sales of blockbuster Soliris—and a welcome settlement with Amgen will give the drugmaker even more breathing room. Alexion reached a deal with Amgen late last week to settle three inter partes patent reviews, staving off U.S. biosimilar versions of Soliris until 2025 unless other challengers join the field, according to a Securities and Exchange Commission filing. Previously, an analyst favored Alexion in the IPR fight but predicted Amgen could launch its biosim as early as 2022 if it prevailed. As part of the settlement, Amgen won a non-exclusive, royalty-free license to market its Soliris biosim beginning March 1, 2025, to treat paroxysmal nocturnal hemoglobinuria (PNH). Soliris is also approved in the U.S. to treat atypical hemolytic uremic syndrome (aHUS), myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD).

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