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Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)

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Trial Profile

Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 27 Sep 2023

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At a glance

  • Drugs Natalizumab (Primary)
  • Indications Multiple sclerosis
  • Focus Registrational; Therapeutic Use
  • Acronyms Antelope
  • Sponsors Polpharma

    • Most Recent Events

    • 26 Sep 2023 According to a Novartis media release, company announced that the European Commission (EC) granted marketing authorization for the first and only biosimilar Tyruko (natalizumab), developed by Polpharma Biologics. Decision based on evidence from extensive analytical characterization demonstrating similarity of biosimilar with reference biologic, in addition to Phase I and confirmatory Phase III studies.
    • 24 Jul 2023 According to a Polpharma Biologics media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), adopted a positive opinion regarding granting marketing authorization for natalizumab for the treatment of multiple sclerosis. The MAA submission was supported by a robust analytical, preclinical and clinical data package including data from this and phase 1 trial.
    • 23 Jan 2023 Results assessing matching efficacy, safety, and immunogenicity between biosim-NTZ and reference natalizumab (ref-NTZ) in patients with relapsing-remitting MS published in the JAMA Neurology

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