> ## 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.

# Bio-Thera BLA for Avastin Biosimilar
- URL: https://www.fdaweb.com/bio-thera-bla-for-avastin-biosimilar/
- Published: 2021-01-28T12:00:00.000Z
- Updated: 2026-09-14T16:44:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148547

FDA has accepted for review a Bio-Thera Solutions BLA for BAT1706, a proposed biosimilar to Genentech’s Avastin (bevacizumab). The submission seeks approval for the following indications: (**1**) treating patients with metastatic colorectal cancer in combination with fluorouracil-based chemotherapy, (**2**) first-line treatment for patients with non-squamous non-small cell lung cancer, (**3**) recurrent glioblastoma, (**4**) metastatic renal cell carcinoma in combination with interferon alfa and, (**5**) persistent, recurrent or metastatic cervical cancer. The agency has set a user fee review action target date of 11/27.

The company says the BLA is based on data from a series of preclinical comparison studies, clinical pharmacokinetic comparison studies, and an international multi-center Phase 3 clinical comparison study that demonstrated that BAT1706 is highly similar to reference bevacizumab in clinical efficacy, safety, and immunogenicity.