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Tanvex submits BLA for TX05 (Herceptin Biosimilar) to FDA

US-based Tanvex BioPharma has submitted its Biologics License Application (BLA) for TX05, a proposed biosimilar to the reference product Herceptin. TX05 is indicated for breast cancer and gastric cancer. The review of BLA would be a 10-month to 12-month time frame.   

According to IQVIA data 2020, the Herceptin sales in US market hit $2.3 billion. There are different treatment options for breast cancer, including biologics such as Herceptin, Avastin, Perjeta and Kadcyla.

News compiled by IBMI; Source in Chinese:

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