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Trastuzumab biosimilar - Prestige BioPharma

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Drug Profile

Trastuzumab biosimilar - Prestige BioPharma

Alternative Names: HD 201; Hervelous; Tuznue

Latest Information Update: 05 Aug 2024

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At a glance

  • Originator Hanwha Biologics
  • Developer Hanwha Biologics; Prestige BioPharma
  • Class Antineoplastics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; 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 Gastric cancer; HER2 positive breast cancer
  • Preregistration Submission Withdrawal Oesophageal cancer
  • No development reported Breast cancer; Cancer

Most Recent Events

  • 01 Aug 2024 Prestige Biopharma receives a positive CHMP opinion from the European Medicines Agency for trastuzumab biosimilar
  • 28 Apr 2024 No recent reports of development identified for phase-I development in Breast-cancer(In volunteers) in Australia (IV, Infusion)
  • 13 Oct 2022 Prestige Biopharma announces intention launch Trastuzumab biosimilar for the treatment of human epidermal growth factor 2 (HER2) positive breast and metastatic gastric cancer in USA

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