BAT 1706 (bevacizumab biosimilar) filed with FDA for colorectal cancer, non-small cell lung cancer, glioblastoma, renal cell carcinoma and cervical cancer.- Bio-Thera Solutions

Bio-Thera Solutions announced that the FDA has accepted its Biologics License Application (BLA) for BAT 1706 (bevacizumab biosimilar), a proposed biosimilar to Avastin. The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is November 27, 2021. The BLA seeks approval of BAT 1706 for the following indications: 1) treatment of 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 BLA submission is based on data from a series of preclinical comparison studies, clinical pharmacokinetic comparison studies, and an international multi-center Phase III clinical comparison study that demonstrated that BAT1706 is highly similar to reference bevacizumab in clinical efficacy, safety, and immunogenicity. Biosimilarity has not yet been established by any regulatory authorities.