Trastuzumab biosimilar - Prestige Biopharma

Drug Profile

Trastuzumab biosimilar - Prestige Biopharma

Alternative Names: HD 201; Hervelous

Latest Information Update: 04 Jul 2018

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At a glance

  • Originator Hanwha Biologics
  • Developer Prestige BioPharma
  • 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.

  • New Molecular Entity No

Highest Development Phases

  • Phase III Breast cancer; Gastric cancer

Most Recent Events

  • 28 Jun 2018 Prestige Biopharma and Alvogen enter into a license and supply agreement in Breast cancer and Gastric cancer in Central and Eastern Europe
  • 28 Jun 2018 Prestige Biopharma expects regulatory filing of trastuzumab biosimilar with the European Medicines Agency and the US FDA in 2019
  • 01 Dec 2017 Phase-III clinical trials in Breast cancer (Combination therapy, Late-stage disease) in Malaysia (IV) (NCT03013504)
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