FDA Approves Samsung Bioepis’ EPYSQLI® (eculizumab-aagh) as
Jul 22, 2024 · EPYSQLI has been approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, atypical hemolytic uremic syndrome …
FDA approves Epysqli, biosimilar of Soliris, as aHUS treatment
Jul 24, 2024 · The U.S. Food and Drug Administration (FDA) has approved Epysqli (eculizumab-aagh), a biosimilar to Soliris (eculizumab), as an atypical hemolytic uremic syndrome (aHUS) …
FDA approves biosimilars: ustekinumab Otulfi and eculizumab Epysqli
Oct 29, 2024 · On 22 July 2024, FDA approved Samsung Bioepis’ Epysqli (eculizumab-aagh) for the treatment of patients with paroxysmal nocturnal haemoglobinuria (PNH) to reduce …
Epysqli, a Soliris biosimilar, approved in US to treat PNH
Jul 29, 2024 · The U.S. Food and Drug Administration (FDA) has approved Epysqli (eculizumab-aagh), a Soliris (eculizumab) biosimilar, to prevent red blood cell destruction (hemolysis) in …
FDA Approves Epysqli as Second Soliris Biosimilar - Center for …
Jul 22, 2024 · The FDA approved Epysqli (eculizumab-aagh), a biosimilar developed by Samsung Bioepis that references Soliris (eculizumab), for the treatment of paroxysmal nocturnal …
FDA Approves Samsung Bioepis’ EPYSQLI® (eculizumab-aagh) as …
Jul 22, 2024 · EPYSQLI has been approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, atypical hemolytic uremic syndrome …
Eculizumab Biosimilar Epysqli Gets FDA Approval - MPR
Jul 22, 2024 · Epysqli, a complement inhibitor, is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, and for the treatment of …
FDA Approval Marks Epysqli as Second Soliris Biosimilar - Drug …
Jul 22, 2024 · Eculizumab-aagh (Epysqli) is the second FDA-approved biosimilar for eculizumab (Soliris), considered the standard treatment for rare diseases PNH and aHUS. High cost is a …
FDA approves Samsung Bioepis’ EPYSQLI as Soliris biosimilar
Jul 23, 2024 · Samsung Bioepis has announced the approval of its EPYSQLI (eculizumab-aagh) biologics licence application (BLA) by the US Food and Drug Administration (FDA) as a …
Samsung Bioepis Presents Totality-of-the-Evidence Supporting ...
“Totality-of-the-evidence”, including analytical, non-clinical and clinical data, supports extrapolation of atypical hemolytic uremic syndrome (aHUS) indication for EPYSQLI.
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