Trastuzumab biosimilar - Samsung Bioepis

Drug Profile

Trastuzumab biosimilar - Samsung Bioepis

Alternative Names: Ontruzant; SB3; Trastuzumab-biosimilar-Samsung Bioepis

Latest Information Update: 11 Oct 2017

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At a glance

  • Originator Samsung Bioepis
  • Class Antineoplastics; Monoclonal antibodies
  • Mechanism of Action ERBB 2 receptor antagonists
  • 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

  • Preregistration Breast cancer; Gastric cancer

Most Recent Events

  • 15 Sep 2017 The EMA's Committee for Medicinal Products for Human Use recommends approval of trastuzumab biosimilar for Breast cancer and Gastric cancer in European Union
  • 08 Sep 2017 Updated safety, efficacy and immunogenicity data from a phase III trial in Breast cancer presented at the 42nd European Society for Medical Oncology Congress (ESMO-2017)
  • 17 May 2017 Efficacy, safety, pharmacokinetic and immunogenicity data from a phase III study in breast cancer presented at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO 2017)
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