Bio-Thera BLA for Avastin Biosimilar

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.