Blog Big Molecule Watch January 30, 2021

FDA Accepts Bio-Thera Solutions’ Biologics License Application for BAT1706, a Proposed Biosimilar to Avastin®

On January 28, 2021, Bio-Thera Solutions announced that the Food and Drug Administration (FDA) accepted its Biologics License Application (BLA) for BAT1706, a proposed biosimilar to Avastin® (bevacizumab).  The BLA seeks approval of BAT1706 for the treatment of diseases for which the US-licensed Avastin is approved, including metastatic colorectal cancer in combination with fluorouracil-based chemotherapy, first-line treatment for non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma in combination with interferon alfa, and recurrent or metastatic cervical cancer.  The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is November 27, 2021.

According to a statement made by Dr. Shengfeng Li, Founder and CEO of Bio-Thera Solution, “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.”  The FDA’s acceptance of Bio-Thera’s BLA for BAT1706 is a “significant achievement that brings Bio-Thera closer to providing cancer patients in the USA with a high-quality, low-cost treatment option.”

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