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Trastuzumab biosimilar - Shanghai Henlius Biotech

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Drug Profile

Trastuzumab biosimilar - Shanghai Henlius Biotech

Alternative Names: Adheroza; Dafex; Hanquyou; HERCESSI; HLX 02; Trastucip; trastuzumab-strf; Tuzucip; Zercepac

Latest Information Update: 24 Sep 2024

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At a glance

  • Originator Shanghai Henlius Biotech
  • Developer Accord Healthcare; Cipla; Shanghai Henlius Biotech
  • 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

  • Marketed Breast cancer; Gastric cancer
  • Registered Adenocarcinoma; HER2 positive breast cancer

Most Recent Events

  • 18 Sep 2024 Trastuzumab biosimilar has a black boxed warning for cardiomyopathy, infusion reactions, embryo-fetal toxicity and pulmonary toxicity
  • 18 Sep 2024 Accord BioPharma announces intention to launch Trastuzumab biosimilar in HER2 positive breast cancer (Adjuvant therapy, Metastatic disease) and Adenocarcinoma (Metastatic disease) in USA in early 2025
  • 18 Sep 2024 US FDA approves 420mg strength of Trastuzumab biosimilar in HER2 positive breast cancer (Adjuvant therapy, Metastatic disease) and Adenocarcinoma (Metastatic disease) in USA

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