EMA Authorised: Epysqli (Eculizumab) — Samsung Bioepis NL B.V.

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Summary

EMA authorised Epysqli, a biosimilar of eculizumab, by Samsung Bioepis NL B.V., for paroxysmal nocturnal hemoglobinuria.

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Diseases / indications

• Paroxysmal Nocturnal Hemoglobinuria

Drugs mentioned

• EPYSQLI (eculizumab-aagh)

Snippet

Status: Authorised. Therapeutic area: Hemoglobinuria, Paroxysmal. MAH: Samsung Bioepis NL B.V.. Decision date: 16/02/2026