Epysqli®

Understanding Epysqli®

Epysqli® (eculizumab-aagh) is a biosimilar to Soliris® (eculizumab), developed by Samsung Bioepis. It is a monoclonal antibody that inhibits complement protein C5, a key component in the immune system’s complement pathway. By blocking C5, Epysqli® prevents the formation of the terminal complement complex, reducing the destruction of red blood cells and mitigating damage to blood vessels. It is used to treat rare, life-threatening blood disorders where excessive complement activation leads to hemolysis and thrombotic microangiopathy.

How Epysqli® Works:

• Binds to complement protein C5, inhibiting its cleavage into C5a and C5b.
• Prevents the formation of the membrane attack complex (C5b-9), reducing red blood cell destruction.
• Decreases hemolysis in paroxysmal nocturnal hemoglobinuria (PNH).
• Inhibits complement-mediated thrombotic microangiopathy in atypical hemolytic uremic syndrome (aHUS).

FDA Approval:

• July 19, 2024 – Approved as a biosimilar to Soliris® for:
  • Treatment of paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.
  • Treatment of atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.
  • Treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive.

Epysqli® is available only through a restricted program called the Epysqli® Risk Evaluation and Mitigation Strategy (REMS) due to the increased risk of serious meningococcal infections. Patients should complete meningococcal vaccination prior to initiating therapy and be monitored for early signs of infection.

For more information, please visit the Epysqli® Website. Speak with your healthcare provider to determine if Actemra® is the right treatment option for you.