> ## 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.

# Mylan/Biocon BLA for Avastin Biosimilar
- URL: https://www.fdaweb.com/mylan-biocon-bla-for-avastin-biosimilar/
- Published: 2020-03-09T12:00:00.000Z
- Updated: 2026-09-14T16:06:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146277

FDA has accepted for review a Mylan/Biocon BLA for MYL-1402O, a biosimilar candidate referencing Genentech’s Avastin (bevacizumab). Avastin is indicated for treating five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma; and persistent, recurrent or metastatic cervical cancer. The agency has set a user fee review action target date of 12/27.

The BLA is supported by data from a Phase 3 clinical trial that evaluated the efficacy, safety and immunogenicity of bevacizumab versus Avastin. The study included patients diagnosed with Stage 4 non-squamous non-small cell lung cancer. A total of 671 patients were randomized. At week 18, the study met the primary endpoint for the best objective response rate ratio, which was within the pre-specified equivalence margin, the companies say. The safety, which included immunogenicity, was found to be similar to Avastin, they say.