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,...
By: Goodwin

Goodwin