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