On November 3, 2021 Tanvex BioPharma, Inc. (TWSE: 6541) reported the submission of its Biologics License Application (BLA) for TX05 to US Food and Drug Administration (FDA) (Press release, Tanvex BioPharma, NOV 3, 2021, View Source [SID1234595071]). This is the second BLA for Tanvex filed with US FDA. TX05 is a proposed biosimilar to the reference product Herceptin (trastuzumab).

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Tanvex announced positive top-line efficacy and safety data from global Phase III clinical trial in Feb. 2021. According to data from IQVIA, Herceptin US sales in 2020 was $2.3 billion (USD).