Trastuzumab biosimilar - Samsung Bioepis

Drug Profile

Trastuzumab biosimilar - Samsung Bioepis

Alternative Names: SB3; Trastuzumab-biosimilar-Samsung Bioepis

Latest Information Update: 11 Jul 2017

$50 / €47 *
* $ price applies to USA, Canada and Latin America. € price applies to the rest of the world. Final gross prices may vary according to local VAT.

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

  • 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)
  • 01 Feb 2017 Samsung Bioepis completes a phase III trial in Breast cancer (Neoadjuvant therapy, Newly diagnosed) in Czech Republic, Romania, Poland and Bulgaria (IV) (EudraCT2013-004172-35)
  • 03 Oct 2016 The European Medicine's Agency accepts MAA for trastuzumab biosimilar for Breast cancer and Gastric cancer for review
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