Epysqli FDA Approval History

Last updated by Judith Stewart, BPharm on July 23, 2024.

FDA Approved: Yes (First approved July 19, 2024)
Brand name: Epysqli
Generic name: eculizumab-aagh
Dosage form: Injection
Company: Samsung Bioepis Co., Ltd.

Epysqli (eculizumab-aagh) is a complement inhibitor biosimilar to Soliris for the treatment of paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.

• Epysqli is indicated for:
  - the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.
  - the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.
  Limitation of Use: Epysqli is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).
• Epysqli is biosimilar to Soliris and does not have an interchangeability designation.
• Epysqli is administered by intravenous infusion over 35 minutes in adults and 1 to 4 hours in pediatric patients.
• FDA approval of Epysqli was based on a totality of evidence including analytical, non-clinical and clinical data demonstrating it is highly similar to Soliris, with no clinically meaningful differences between Epysqli and Soliris in terms of safety, purity and potency.
• Epysqli comes with a Boxed Warning for serious meningococcal infections. Epysqli is available only through a restricted program called Epysqli REMS. Warnings and precautions associated with Epysqli include caution when administering Epysqli to patients with any other systemic infection, and infusion-related reactions.
• Common adverse reactions:
  - in PNH patients include headache, nasopharyngitis, back pain, and nausea.
  - in aHUS patients include headache, diarrhea, hypertension, upper respiratory infection, abdominal pain, vomiting, nasopharyngitis, anemia, cough, peripheral edema, nausea, urinary tract infections, and pyrexia.
• Epysqli is the second FDA-approved Soliris biosimilar, following the approval of Bkemv (eculizumab-aeeb) in May 2024.

Development timeline for Epysqli

Further information

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