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Pharmacokinetic Study Comparing Hercules, EU-approved Herceptin and US-Licensed Herceptin Administered as a Single Intravenous Infusion to Healthy Male Volunteers

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Trial Profile

Pharmacokinetic Study Comparing Hercules, EU-approved Herceptin and US-Licensed Herceptin Administered as a Single Intravenous Infusion to Healthy Male Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 04 Aug 2022

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At a glance

  • Drugs Trastuzumab (Primary)
  • Indications Breast cancer; Gastric cancer; Male breast cancer
  • Focus Pharmacokinetics
  • Sponsors Mylan Pharmaceuticals

    • Most Recent Events

    • 12 Jun 2018 Results published in the British Journal of Clinical Pharmacology.
    • 01 Dec 2017 According to a Mylan media release, the U.S. Food and Drug Administration approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+).
    • 13 Jul 2017 According to a Mylan media release, the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of the companies proposed biosimilar trastuzumab. The committee voted 16-0 in support of eligible indications of the reference product, Herceptin, which include HER2-positive breast cancer in the metastatic and adjuvant settings.

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