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: 13 Jul 2017

At a glance

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

    • 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.
    • 08 Nov 2016 According to a Mylan media release, based on the data of two pharmacokinetic studies and HERITAGE trial company has submitted a biologics license application (BLA) for MYL-1401O to the U.S. Food and Drug Administration (FDA) through the 351(K) pathway.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top