BLA for Proposed Trastuzumab Biosimilar Submitted to FDA

Mylan has submitted a biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, to the U.S. Food and Drug Administration (FDA). Genentech’s trastuzumab is approved by the FDA for the treatment of human epidermal growth factor receptor 2 (HER2)-positive breast and gastric cancers.¹

This submission is based on findings from the phase 3 HERITAGE study (ClinicalTrials.gov Identifier: NCT02472964), which showed that 69.6% of patients treated with the biosimilar achieved an objective response compared with 64% of patients who received trastuzumab.

Neutropenia was the most frequently reported serious adverse event in both arms; there was no difference in the incidence of cardiac toxicity between the 2 groups.

The study enrolled 500 patients with centrally confirmed, measurable, HER2-positive, metastatic breast cancer who had not received prior chemotherapy or trastuzumab for metastatic disease. Participants were randomly assigned 1:1 to receive MYL1401O or trastuzumab, both in combination with docetaxel or paclitaxel for at least 8 cycles.

A biosimilar agent is a biologic product that is highly similar to an already approved product with respect to potency, safety, and purity. No biosimilars are approved for the treatment of cancer in the United States, though filgrastim-sndz is approved as a biosimilar to filgrastim for the treatment of neutropenia.                       

Reference

1. Mylan and Biocon announce U.S. FDA submission for proposed biosimilar trastuzumab. Mylan website. http://newsroom.mylan.com/2016-11-08-Mylan-and-Biocon-Announce-U-S-FDA-Submission-for-Proposed-Biosimilar-Trastuzumab. Updated November 8, 2016. Accessed November 9, 2016.