Trastuzumab biosimilar - Merck & Co./Samsung Bioepis

Drug Profile

Trastuzumab biosimilar - Merck & Co./Samsung Bioepis

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

Latest Information Update: 21 Dec 2017

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At a glance

  • Originator Samsung Bioepis
  • Developer Merck & Co; 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

  • Registered Breast cancer; Gastric cancer

Most Recent Events

  • 19 Dec 2017 Preregistration for Breast cancer in USA (IV)
  • 19 Dec 2017 The US FDA accepts BLA for trastuzumab biosimilar for Breast cancer for review
  • 19 Nov 2017 Registered for Breast cancer (Early-stage disease) in Liechtenstein, Iceland, Norway, European Union (IV)
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