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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: 24 Jan 2025

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At a glance

  • Originator Samsung Bioepis
  • 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

  • Registered Atypical Haemolytic Uraemic Syndrome; Paroxysmal nocturnal haemoglobinuria

Most Recent Events

  • 10 Jan 2025 Eculizumab biosimilar licensed to Teva Pharmaceutical Industries in USA
  • 23 Sep 2024 Pharmacodynamics data from a preclinical trial in Paroxysmal nocturnal hemoglobinuria released by Samsung Bioepis
  • 22 Jul 2024 Preregistration for Atypical haemolytic uraemic syndrome in USA, South Korea (IV), prior to July 2024

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