> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA OKs Herceptin Biosimilar Multi-dose Vial
- URL: https://www.fdaweb.com/fda-oks-herceptin-biosimilar-multi-dose-vial/
- Published: 2020-03-25T12:00:00.000Z
- Updated: 2026-09-14T16:08:44.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5146416

FDA has approved a Samsung Bioepis supplemental BLA for a 420 mg multi-dose vial of Ontruzant (trastuzumab-dttb), a biosimilar referencing Genentech’s Herceptin. Ontruzant was approved 1/2019 as a 150mg single-dose vial for use in treating HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer or gastroesophageal junction adenocarcinoma in patients who have not received prior treatment for metastatic disease.