On January 28, 2021, Bio-Thera Solutions, Ltd., a biopharmaceutical company based in China, announced that the U.S. Food and Drug Administration (FDA) accepted its Biologics License Application (BLA) for BAT1706, a proposed biosimilar to bevacizumab, referencing Genentech’s Avastin®, but excluding indications under orphan drug exclusivity protection.  The FDA has set November 27, 2021, as the decision date for the application.

Bevacizumab is an angiogenesis inhibitor, which suppresses new blood vessel growth in tumors by inhibiting vascular endothelial growth factor A.  Bio-Thera’s BLA seeks approval of BAT1706 for the treatment of metastatic colorectal cancer in combination with fluorouracil-based chemotherapy, non-squamous non–small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma in combination with interferon α, and persistent, recurrent, or metastatic cervical cancer.

Bio-Thera also filed for regulatory approval for BAT1706 in China and the European Union.  In December 2020, Bio-Thera announced a partnership with Brazil-based Biomm for the commercialization of BAT1706 in Brazil.  Bio-Thera has also commercialized a biosimilar of adalimumab, referencing Abbvie’s Humira®, and received marketing authorization in China.  Bio-Thera is also developing additional biosimilar products including tocilizumab, golimumab, ustekinumab and secukinumab, and mepolizumab.

“The FDA’s acceptance of our BLA is a significant achievement that brings Bio-Thera closer to providing cancer patients in the USA with a high-quality, low-cost treatment option,” said Dr. Shengfeng Li, Founder and CEO of Bio-Thera Solutions. “Regulatory filings for BAT1706 have now been accepted by the China National Medical Products Administration (NMPA), European Medicines Agency (EMA) 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.”

In the U.S., two bevacizumab biosimilars have been approved: Mvasi launched by Amgen in July 2019 and Zirabev by Pfizer in January 2020.  The FDA’s acceptance of the BLA added Bio-Thera to a list of biosimilar developers, including Amgen, Pfizer, Samsung Bioepis, Centus, and Mylan, to report the filing of a BLA for a bevacizumab biosimilar.