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Teva and Samsung Bioepis Launch EPYSQLI in the U.S.

EPYSQLI is designed to treat gMG in adults who are anti-acetylcholine receptor antibody positive.

By: Rachel Klemovitch

Assistant Editor

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries, and Samsung Bioepis announced the availability of EPYSQLI (eculizumab-aagh) in the U.S. EPYSQLI is a biosimilar to Soliris (eculizumab) to treat paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS) and generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive. 

In July 2024, the FDA approved EPYSQLI as a biosimilar to Soliris to treat patients with PNH to reduce hemolysis, and aHUS to inhibit complement-mediated thrombotic microangiopathy. In November 2024, its indication was expanded to include the treatment of gMG in adult patients who are AchR antibody-positive. 

The FDA has provisionally determined that EPYSQLI will be interchangeable with the reference biologic Soliris, following the expiration of exclusivity for the first interchangeable biosimilar.

EPYSQLI is a paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis and an atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.

EPYSQLI will be offered at a 30% discount on the Wholesale Acquisition Cost (WAC) of Soliris in the U.S.

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