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

Trial Profile

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

Completed
Phase of Trial: Phase I

Latest Information Update: 01 Dec 2017

At a glance

  • Drugs Trastuzumab (Primary)
  • Indications Breast cancer
  • Focus Pharmacokinetics
  • Sponsors Mylan Pharmaceuticals
  • Most Recent Events

    • 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.
    • 11 Jan 2017 According to a Mylan media release, the U.S. Food and Drug Administration (FDA) has accepted Mylan's biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, for filing through the 351(k) pathway. The anticipated FDA goal date set under the Biosimilar User Fee Act (BsUFA) is Sept. 3, 2017.
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