FDA Accepts Biologics License Application for Proposed Biosimilar Trastuzumab

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The FDA has accepted Mylan's Biologics License Application (BLA) for MYL-1401O.
The FDA has accepted Mylan's Biologics License Application (BLA) for MYL-1401O.

The U.S. Food and Drug Administration (FDA) has accepted Mylan's Biologics License Application (BLA) for MYL-1401O, a proposed biosimilar to branded trastuzumab (Herceptin), a human epidermal growth factor receptor 2 (HER2)/neu receptor antagonist indicated for the treatment of HER2-overexpressing breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma.1

The BLA submission is based on findings from the multicenter, double-blind, phase 3 HERITAGE trial (ClinicalTrials.gov Identifier: NCT02472964), which evaluated the efficacy and safety of MYL-1401O plus paclitaxel or docetaxel compared with trastuzumab plus a taxane in 458 treatment-naive women with ERBB2 (HER2)-positive metastatic breast cancer.

Results of the study showed that 69.6% (95% CI, 63.62-75.51) of patients who received the proposed biosimilar achieved a response by week 24 compared with 64.0% (95% CI, 57.81-70.26) of those given trastuzumab.

There was no statistically significant difference in progression-free survival, time to tumor progression, or overall survival between the 2 treatment arms at week 48.

RELATED: Biosimilar to Trastuzumab Has Equivalent Activity in Breast Cancer

The safety profiles of the 2 agents were similar, with the most frequently reported adverse events being neutropenia, peripheral neuropathy, and diarrhea.

The FDA is expected to take action on the BLA by September 3, 2017. If approved, MYL-14010 could be the first biosimilar trastuzumab in the US.


  1. U.S. FDA accepts Biologics License Application (BLA) for Mylan and Biocon's proposed biosimilar trastuzumab. Mylan website. http://newsroom.mylan.com/2017-01-11-U-S-FDA-Accepts-Biologics-License-Application-BLA-for-Mylan-and-Biocons-Proposed-Biosimilar-Trastuzumab. Published January 11, 2017. Accessed January 11, 2017.

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