Tanvex BioPharma' first biosimilar, TX01, received approval for its Biologics License Application (BLA) from the U.S. Food and Drug Administration (FDA) on June 29, Taiwan time. This milestone allows TX01 to enter the world's largest biosimilar market. It marks the first FDA-approved biosimilar from Taiwan and is also the first FDA-approved filgrastim biosimilar from Asia.

Lin-Cheng Chen, Chairman and CEO of Tanvex BioPharma, stated that obtaining FDA approval is a significant milestone for the company, officially establishing Tanvex as a comprehensive biopharmaceutical company. In addition to independently developing biosimilars, Tanvex has now begun offering Contract Development and Manufacturing Organization (CDMO) services for biopharmaceuticals. From cell line development to passing FDA inspections and obtaining BLA approval, Tanvex has accumulated extensive experience. With this FDA approval, renowned for its stringent review process, and with a cGMP facility located in the United States, Tanvex is well-prepared to advance in product commercialization and CDMO business.

The biosimilar TX01, marketed under the name Nypozi, is based on the reference drug Neupogen (filgrastim) and is indicated for treating neutropenia caused by cancer chemotherapy. This is the fourth FDA-approved filgrastim biosimilar. According to IQVIA data, as of March 2024, the U.S. market for filgrastim was worth $403 million, while the Canadian market was valued at $65 million. Tanvex BioPharma' Nypozi has been available in Canada since January of this year.

Resource (mandarin) : 報喜！泰福-KY首個生物相似藥TX01獲美FDA上市許可