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Trastuzumab biosimilar - Tanvex Biopharma

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Drug Profile

Trastuzumab biosimilar - Tanvex Biopharma

Alternative Names: TX-05

Latest Information Update: 10 Feb 2026

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At a glance

  • Originator Tanvex 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 HER2 positive breast cancer

Most Recent Events

  • 10 Feb 2026 No development reported - Phase-III for HER2-positive-breast-cancer (Early-stage disease, Neoadjuvant therapy) in Peru, India, Chile, Russia, Bulgaria, Hungary (IV)
  • 10 Feb 2026 No development reported - Phase-III for HER2-positive-breast-cancer (Neoadjuvant therapy, Early-stage disease) in Philippines, Mexico, Belarus, Ukraine, Georgia (IV)
  • 06 Jul 2024 Tanvex Biopharma resubmits the BLA for trastuzumab biosimilar to the US FDA

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