Trastuzumab biosimilar - Celltrion

Drug Profile

Trastuzumab biosimilar - Celltrion

Alternative Names: CT-P06; CT-P6; Herzuma

Latest Information Update: 11 Apr 2018

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At a glance

  • Originator Celltrion
  • Developer Celltrion; Nippon Kayaku; Teva Pharmaceutical Industries
  • Class Antineoplastics; Monoclonal antibodies
  • Mechanism of Action ERBB 2 receptor antagonists; Immunomodulators
  • 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

  • Marketed Breast cancer; Gastric cancer

Most Recent Events

  • 10 Apr 2018 Celltrion receives complete response letter from the FDA for Trastuzumab biosimilar in Breast cancer and Gastric cancer (Metastatic disease)
  • 23 Mar 2018 Registered for Gastric cancer in Japan (IV)
  • 13 Feb 2018 Registered for Breast cancer in Liechtenstein, Liechtenstein, Iceland, Norway, European Union (IV)
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