If approved, the biosimilar will be indicated for use in metastatic colorectal cancer, nonsquamous non–small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, and metastatic cervical cancer.
The FDA has accepted a biologics license application (BLA) for BAT1706, a proposed biosimilar to bevacizumab (Avastin), according to an announcement made by Bio-Thera Solutions.1 If approved, the biosimilar will be indicated for use in the treatment of patients with metastatic colorectal cancer plus fluorouracil-based chemotherapy, the frontline treatment of patients with nonsquamous non—small cell lung cancer (NSCLC), recurrent glioblastoma, metastatic renal cell carcinoma plus interferon alfa, and persistent, recurrent, or metastatic cervical cancer.
The application is supported by data from a series of preclinical comparison studies, clinical pharmacokinetic comparison studies, as well as an international multicenter phase 3 comparison study (NCT03329911), which showed that the biosimilar was similar to the reference product with regard to safety, efficacy, and immunogenicity. However, biosimilarity has yet to be established by regulatory authorities. Under the Biosimilar Fee Act, the regulatory agency will make a decision on the product by November 27, 2021.
“The FDA’s acceptance of our BLA is a significant achievement that brings Bio-Thera closer to providing cancer patients in the United States with a high-quality, low-cost treatment option,” Shengfeng Li, PhD, founder and CEO of Bio-Thera Solutions, stated in the press release. “Regulatory filings for BAT1706 have now been accepted by the China National Medical Products Administration, European Medicines Agency, and FDA, demonstrating Bio-Thera’s commitment to developing BAT1706 to global standards so that BAT1706 can be made available to the global cancer patient community.”