Trastuzumab biosimilar - Samsung Bioepis

Drug Profile

Trastuzumab biosimilar - Samsung Bioepis

Alternative Names: SB3; Trastuzumab-biosimilar-Samsung Bioepis

Latest Information Update: 06 Oct 2016

Price : $50

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
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity No

Highest Development Phases

  • Preregistration Breast cancer; Gastric cancer

Most Recent Events

  • 03 Oct 2016 The European Medicine's Agency accepts MAA for trastuzumab biosimilar for Breast cancer and Gastric cancer for review
  • 31 Aug 2016 Preregistration for Breast cancer in European Union (IV)
  • 31 Aug 2016 Preregistration for Gastric cancer in European Union (IV)
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