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Eculizumab biosimilar - Samsung Bioepis

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Drug Profile

Eculizumab biosimilar - Samsung Bioepis

Alternative Names: AMT-904; EPYSQLI; SB-12 - Samsung Bioepis

Latest Information Update: 06 Jan 2026

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At a glance

  • Originator Samsung Bioepis
  • Developer Samsung Bioepis; Teva Pharmaceutical Industries
  • Class Anti-inflammatories; Antiallergics; Antianaemics; Antiasthmatics; Antihypertensives; Antipsoriatics; Antirheumatics; Eye disorder therapies; Monoclonal antibodies; Neuroprotectants; Skin disorder therapies; Urologics
  • Mechanism of Action Complement C5 inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Atypical Haemolytic Uraemic Syndrome; Myasthenia gravis; Paroxysmal nocturnal haemoglobinuria

Most Recent Events

  • 02 Jan 2026 Launched for Atypical haemolytic uraemic syndrome (In adults, In adolescents, In children) in European Union (IV)
  • 02 Jan 2026 Launched for Paroxysmal nocturnal haemoglobinuria (In children, In adolescents, In adults) in European Union (IV)
  • 12 Jun 2025 Updated long term adverse event data from a phase III trial in Paroxysmal nocturnal hemoglobinuria released by Samsung Bioepis

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